bluuebunny/crossref_metadata_2025 huggingface dataset:
SHORT-TERM BLOOD PRESSURE ALTERATIONS AFTER COVID-19 VACCINATION
Authors: Sanidas Elias , Papadopoulos Dimitrios , Anastasiou Theoharis , Velliou Maria , Michalaki Eftixia , Fotsali Anastasia , Golemati Spyretta , Mantzourani Marina , Barbetseas John
Published: June 2022

Objective:

A non-immediate hypertensive response short after COVID-19 vaccination has been reported. Mild to moderate elevated arterial blood pressure (BP) levels have been documented few days after a single or two-doses vaccine. This study sought to investigate this observation as a potential side effect in patients with known hypertension and healthy controls.

Design and method:

A total of 100 vaccinated patients between the age of 50 to 70 years old were studied. They were randomly assigned to one of the approved and available vaccines (Pfizer, Astra Zeneca, Moderna, Johnson & Johnson). Half of them were hypertensives under medical treatment and half of them were not. All participants had systolic BP < 140mmHg and diastolic BP < 90mmHg before vaccination and volunteered for standard daily home BP measurements (HBPM) and ambulatory BP measurements (ABPM) between the 1st and the 21st day after considered fully COVID-19 vaccinated.

Results:

All patients, hypertensives or not, had at some point a recorded hypertensive response for both systolic (SBP) and diastolic (DBP) BP after considered fully vaccinated. Hypertensives were older and with higher body mass index (BMI). Some of the hypertensive patients received additional medication whereas some of the non-hypertensive patients started life modification changes and systematic BP measurements for a possible diagnosis of hypertension.

Conclusions:

Vaccination for COVID-19 seems to be related with a short period of hypertensive response. This phenomenon was partial and mostly observed in older overweight hypertensives.
OPTIMIZATION OF BLOOD PRESSURE CONTROL AND ANGIOPROTECTION WITH FIXED COMBINATION OF LISINOPRIL + AMLODIPINE + ROSUVASTATIN IN PATIENTS AFTER A COVID-19
Authors: Nedogoda Sergey , Ledyaeva Alla , Chumachek Elena , Tsoma Vera , Salasyuk Alla , Lutova Viktoriya , Popova Ekaterina , Vlasov Daniil , Bychkova Olga , Labaznikova Viktoriya , Evdokimov Konstantin
Published: June 2022

Objective:

Evaluation of the capability of a fixed combination of lisinopril + amlodipine + rosuvastatin (ECWAMER) in achieving additional angioprotection in patients with arterial hypertension (AH) and high pulse wave velocity (PWV) in patients after confirmed COVID-19 had 75 – 95% lung involvement, complicated by bilateral polysegmental viral pneumonia, with genetically engineered biological drugs (GIBD) therapy, who had not previously received combined antihypertensive therapy (AHT).

Design and method:

An open-label observational study with a duration of 12 weeks has been carried out. 30 patients who not previously received combined AHT was included. Patients underwent daily monitoring of blood pressure (ABPM), applanation tonometry (determination of the augmentation index (IA) and central blood pressure (CSAD)), measurement of PWV, laboratory tests (lipid composition of blood, fasting glucose, C-reactive protein - CRP, OAC, ferritin, fibrinogen, D-dimer, ALT, AST, creatinine, uric acid) before and after prescribing a fixed combination of lisinopril + amlodipine + rosuvastatin (ECVAMER).

Results:

At baseline, the patients had an increase in office blood pressure to 152.6 / 89.1 mm Hg. After prescribing a fixed combination of lisinopril + amlodipine + rosuvastatin, there was a decrease in systolic blood pressure (SBP) by 15.8% and diastolic blood pressure (DBP) by 12.2%. According to ABPM data, the decrease in SBP was 15% and DBP - 9%, decreased PWV by 23.8%, IA by 9%, CSAP by 12.4% (p < 0.05 for all comparisons with the baseline value). Vascular age (SV) was initially increased to 41.9 years with a passport age of 35.03 years. After the end of therapy, there was a significant decrease in CO up to 36.5 years, LDL by 46.8%, triglycerides by 16.8% and an increase in HDL by 10.7% (p < 0.05 for all comparisons with the baseline value). In addition, the levels of CRP, fibrinogen, D-dimer, glucose, and uric acid significantly decreased.

Conclusions:

The fixed combination of lisinopril + amlodipine + rosuvastatin provides better blood pressure control, improved vascular elasticity, and also improves lipid and carbohydrate metabolism in patients, reduces inflammation in patients with hypertension and hyperlipidemia after suffering from severe and extremely severe COVID-19.
FACTORS THAT INFLUENCE THE SURVIVAL RATE IN PATIENTS WITH COVID-19 WITH A PREVIOUS DIAGNOSIS OF HYPERTENSION AND/OR DIABETES: A SYSTEMATIC REVIEW
Authors: Montealegre Leslie , Amador Eulalia , Pulido Tammy , Rebolledo Roberto , Olvera Lisbeth , Pacheco Brenda
Published: June 2022

Objective:

To determine through the systematic review the survival rate of patients infected by SARS-CoV-2 and previously diagnosed with arterial hypertension and/or diabetes

Design and method:

A systematic review of the literature, in eight electronic and bibliographic databases, was conducted from July 8 to 21, 2020. Different combinations of the terms DECS and MESH were used as: (‘SARS-CoV-2’ OR ‘COVID-19’) AND (‘diabetes’ OR ‘arterial hypertension’) AND (‘Survival rate’ OR ‘Prevalence rates’). The selected articles are retrospective, single-center or multi-center, observational cohort studies of patients with COVID-19 disease who had diabetes and/or arterial hypertension. These were subjected to risk of bias assessment, with the help of critical and methodological guidelines (STROBE) and level of evidence (CEBM).

Results:

326 articles were analyzed by title and type of study, of which 20 were considered relevant. Finally, five retrospective cohort studies that met the inclusion criteria, made in Wuhan, China, were included in this review. All the selected studies affirm that diabetes and hypertension are related to a decrease in the survival rate in patients with COVID-19. Three studies with evidence level 2b and grade of recommendation B, mention factors related to an increase in the survival rate, these are: well-controlled blood glucose, which maintains glycemic variability within 70.26 to 180.16 mg/dL (3.9 to 10.0 mmol/L), patients on pre-admission antihypertensive therapy for SARS-CoV-2 and diabetic patients who do not require insulin may have a lower risk of disease progression and a better prognosis. Additionally, two articles with evidence level 2b and grade of recommendation B, mention the survival rates of 10.6 and 13.9% for diabetics, while 18.8 and 23.4% for hypertensive patients.

Conclusions:

Based on the evidence included in this review, until now, having comorbidities predisposes patients with COVID-19 to a lower probability of survival. It is recommended to consider that adequate glycemic control and blood pressure are guidelines that benefit the recovery of these patients. However, more studies are needed to identify possible preventive and therapeutic strategies for a more comprehensive management of these patients.
SELF-ASSESSMENT OF VITAL SIGNS AND SYMPTOMS OF COVID-19: BLOOD PRESSURE MEASUREMENTS RESULTS FROM THE HYTECC STUDY
Authors: Michaud André , Cloutier Lyne , Vadeboncoeur Alain , Goupil Rémi
Published: June 2022

Objective:

Little is known about the impact of a positive SARS-CoV-2 PCR test and self-isolation at home on blood pressure (BP) values. Moreover, the association between BP values and COVID-19 symptoms is poorly described. The objective of this study was to assess the feasibility of a remote initiation of home health surveillance, including home blood pressure monitoring (HBPM), carried out by confined hypertensive adults diagnosed with COVID-19.

Design and method:

Individuals included in the study were between 40 and 69 years old with a known diagnosis of hypertension and a recent positive SARS-CoV-2 PCR test. After initial phone contact, each participant received at home the equipment needed for vital signs assessment, including a LifeSourceâ UA-651BLE BP monitoring device and access to a web-based platform. The Sphygmoâ mobile app was used by the participants for the electronic transmission of results. Participants had to assess their symptoms and complete vital signs including two BP measurements, twice a day, for 14 consecutive days. Abnormally low BP was defined as a systolic BP < 100 mm Hg. Written guidance was provided to participants on the correct method to perform the various vital signs measurements and data collection. Correlation test was calculated between the proportions of abnormal values of vital signs and severe symptoms.

Results:

A total of 46 participants completed the study. The mean age was 54.1 ± 6.9 years and 54% of participants were men. On average, participants performed 54 BP measurements, 12.3 days of measurements, and 4.4 BP measurements per day. 30.4% (n = 14) of participants had at least 1 systolic BP measurement that was abnormally low (mean of 2.5 abnormally low systolic BP, range 1 to 6). Abnormally low systolic BP was not significantly correlated with the severity of COVID-19 symptoms.

Conclusions:

In a pandemic context, among hypertensive participants with a positive SARS-CoV-2 PCR test, the remote initiation of HBPM with electronic transmission of results is feasible. Moreover, participants were able to perform nearly fourteen days of BP measurements including self-assessment of symptoms, twice a day, and transmit their data using a mobile app and a web-based platform.
THE PROGNOSTIC VALUE OF THE BIOLOGICAL PROFILE OF INFLAMMATION AND COAGULATION AT HYPERTENSIVE PATIENTS AFTER COVID-19
Authors: Gavrila Adrian
Published: June 2022

Objective:

The objective of the study was to estimate how the proinflammatory and prothrombotic imbalances correlates with cardiovascular and renal events at hypertensive patients (pts) after Covid-19.

Design and method:

40 hypertensive pts, (mean age 58.5 ± 9.6 years, 52.5% males)=group 1 and 40 hypertensive pts recovered after Covid-19, matched for age and sex (mean age 60.4 ± 10.8 years, 55% males)=group 2. Inflammation profile was estimated by serum measurement of C reactive protein (CRP), ferritin (F), interleukin 6 (IL6) and fibrinogen (Fb). Prothrombotic profile was determined by serum measurement of D-Dimer (DD). All pts were evaluated during one year, in order to detect the following complications: unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), ischemic stroke (IS), renal dysfunction (RD): microalbuminuria, proteinuria, chronic kidney disease.

Results:

In group 1, UA was significantly associated with higher level of CRP (2.25 ± 0.65 mg/L vs 7.32 ± 1.18 mg/L, p = 0.04). In the same group, RD was found in a higher proportion at pts with increased CRP (2.10 ± 0.56 mg/L vs 8.11 ± 1.21 mg/L, p = 0.02).

In group 2, UA was also significantly associated with higher level of CRP (3.44 ± 0.62 mg/L vs 9.68 ± 1.15 mg/L, p = 0.03) and with greater proportion of DD (0.35 ± 0.08 mcg/ml vs 1.53 ± 0.12 mcg/ml, p = 0.01). NSTEMI was found in a higher proportion at pts with increased DD (0.42 ± 0.07 mcg/ml vs 1.87 ± 0.15 mcg/ml, p = 0.01). In the same group, RD was significantly more frequent at pts with higher level of IL6 (4.55 ± 0.92 pg/ml vs 8.32 ± 0.85 pg/ml, p = 0.04) and with greater level of F (76 ± 15 ng/ml vs 635 ± 26 ng/ml, p = 0.01).

Conclusions:

Proinflammatory status seems to predict a worse midterm outcome (one year) concerning cardiovascular and renal events at hypertensive pts, especially after Covid-19.

Moreover, proinflammatory and prothrombotic imbalances appears to have more powerful midterm prognostic value for incidence of acute coronary syndromes without ST-segment elevation and for incidence of RD at hypertensive pts recovered after Covid-19.
SURGICAL MASKS AND UNATTENDED BLOOD PRESSURE CHANGES IN TREATED HYPERTENSIVE PATIENTS
Authors: Polyzos Dimitris , Konstantinidis Dimitris , Drogkaris Sotiris , Tatakis Fotis , Manta Eleni , Kariori Maria , Siafi Eirini , Filippou Christina , Chalmoukou Konstantina , Thomopoulos Costas , Tsioufis Konstantinos
Published: June 2022

Objective:

Although the effect of face masks on preventing airborne transmission of SARS-CoV-2 is well studied, few data are available on their effects on physiological measures and no study has evaluated their effect on blood pressure (BP). The purpose of our study was to investigate the effect of surgical masks on BP in drug-treated hypertensive patients who had a routine follow-up visit to a university hospital outpatient hypertension clinic.

Design and method:

The study included already treated hypertensive patients aged > 18 years, while the exclusion criteria were atrial fibrillation or any other arrhythmia affecting the BP measurement, an arm circumference > 42 cm, mental disorders, Parkinson’s disease, pregnancy, intolerance to the BP measurement method, or unwillingness to participate. Following the routine mask-on office BP measurement, patients were left alone and randomized to automated office BP measurement, with measurements taken after first wearing a mask for 10 min, then without wearing the mask for 10 min, and vice versa.

Results:

A total number of 265 patients were included in the study. Among the participants, 115 were women (43.4%), the mean age was 62 ± 12 years, and the mean office BP was 134 ± 15/81 ± 12 mmHg. There was no significant difference between mask-on unattended systolic BP (133 ± 15 mmHg) and mask-off unattended systolic BP (132 ± 15 mmHg) (P = 0.13) or between mask-on unattended diastolic BP (77 ± 13 mmHg) and mask-off unattended diastolic BP (76 ± 13 mmHg) (P = 0.32). Moreover, there was no difference in the heart rate (mask-on, 69 ± 11 bpm; mask-off, 69 ± 11 bpm, P = 0.7).

Conclusions:

The results of our study indicate that common surgical masks do not affect systolic/diastolic BP levels during unattended BP measurements.
EFFECT OF HYPERTENSION AND RAS INHIBITORS TO ADULT PATIENTS (OVER 18 YEARS OLD) WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV2) INFECTION WHO WERE ADMITTED TO HOSPital
Authors: Fejes Imola , Róka Richárd , Ábrahám György , Várkonyi Tamás , Lengyel Csaba , Légrády Péter
Published: June 2022

Objective:

A meta-analysis published in March 2021 concluded that neither the ACE inhibitor nor ARB treatment came together with a higher COVID-19 mortality rate. Our aim was to assess the prevalence of treated HT, the number of antihypertensives and ACE-inhibitors or ARBs of them among Covid-positive patients older than 18 years admitted to the Center for Disease Control 1 of Department of Medicine of the University of Szeged.

Design and method:

Data of 165 randomly selected patients (mean age 59.9 ± 12.9 yrs., mean BMI 30.7 + 6.6 kg/m2.) were analysed retrospectively. They were admitted between middle of February and end of April 2021.

Results:

At the time of admission there were 103 (62.4% of all) HT patients (56 men, 47 women). The mean duration of HT was 12.9 ± 6.1 years. The mean number of antihypertensive drugs were 1.6 ± 1.6 pieces (max. 6) at the time of admission. At home 23 patients took more than 3 antihypertensives and 25 patients took exactly 3 drugs. At home 20 patients had monotherapy. The antihypertensive therapy did not change in 74 cases, decreased in 6 cases and increased in 31 cases. In one case we could reduce therapy with 100%, monotherapy was finished, in the other 5 cases it was reduced by 50%.

HT patients spent more days in hospital than non-HT patients (10.9 ± 6.8 vs. 9.2 ± 6.3). Spontaneous oxygen saturation (SatO2) was lower in HT patients compared to non-HTs at admission (89.6 ± 9.7% vs. 92.6 ± 4.8) and patients who were on ARBs had the lowest SatO2 (87.5 ± 8.5%, p = 0.01 vs. non-HT). The total mortality rate was 8.7 % in HT patients and it was just 1.6% in non-HT patients. 16.3% of HT patients with RAS-inhibitors and 13.0% without it required admission to the intensive care unit. The mortality rate was 10 % of patients with RAS-inhibitors and 4.3 % of them without it. The mortality rate was 10% of patients with RAS-inhibitors and 4.3% without it. This rate was 13% in patients with ARB and 8.8% with ACE-inhibitor.

Conclusions:

According to our results, HT may have higher risk for Covid outcomes, including RAS-inhibitors also have a higher risk.
EFFECTS OF SGLT-2 INHIBITORS ON 24H AMBULATORY BLOOD PRESSURE IN PATIENTS WITH TYPE 2 DIABETIC AND HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS
Authors: Wang Qiongying , Tian Li , Sun Runmin , Qi Miaomiao , Yu Jing , Bai Feng
Published: June 2022

Objective:

To analyze the effects of different types of sodium-glucose cotransporter 2 inhibitors (SGLT2i) on 24-hour ambulatory blood pressure in patients with type 2 diabetes mellitus and hypertension.

Design and method:

In the meta-analysis, The PubMed, Web of science, and Cochrane Library were searched for relevant literature, and the references obtained from these sources were retrieved from inception till December 2020. The inclusion and exclusion criteria were formulated in accordance with the requirements of Cochrane systematic review. A total of 1354 articles were retrieved, 592 duplicate articles were excluded, 372 articles were excluded after reading the title and abstract, 87 articles were excluded from non-randomized control and irrelevant outcome indicators, and 7 studies with 2343 patients were finally included. Use RevMan5.3 software to compare the changes in 24-hour ambulatory blood pressure, day and night blood pressure of patients with type 2 diabetes and hypertension before and after treatment with different types and doses of SGLT2i.

Results:

A total of four types of SGLT-2i were evaluated in the application of patients with type 2 diabetes and hypertension. The result showed that compared with placebo,SGLT2i could reduce the 24-hour systolic blood pressure of patients with type 2 diabetes and hypertension by 4.36mmHg (95%CI -5.92--2.79,p < 0.001),among which the antihypertensive effects of empagliflozin, canagliflozin, dapagliflozin and ertugliflozin were -4.59mmHg, -3.74mmHg, -5.06mmHg, -3.64mmHg, respectively; similarly, the 24-hour dynamic diastolic blood pressure decreased by 2.20mmHg (95%CI -2.74, -1.65,p < 0.001), among which the antihypertensive effects of empagliflozin, canagliflozin, dapagliflozin and ertugliflozin were -2.38mmHg, -1.22mmHg, -2.00mmHg,- 2.69mmHg, respectively. At the same time, the systolic and diastolic blood pressure during the day and night decreased significantly.

Conclusions:

his meta-analysis shows that SGLT2i can have beneficial effects on the cardiovascular system by reducing 24-hour ambulatory blood pressure in patients with type 2 diabetes and hypertension, other than reducing blood sugar. Therefore, for patients with type 2 diabetes and hypertension, SGLT2i may be the best hypoglycemic choice.
NIGHT-TIME BLOOD PRESSURE IN DIABETES TYPE-1 ASSESSED BY HOME VS. AMBULATORY MONITORING: A PILOT STUDY
Authors: Menti Ariadni , Kollias Anastasios , Bountzona Ioanna , Konstantakopoulos Sotiris , Servos George , Vazeou Andriani , Stergiou George S.
Published: June 2022

Objective:

To compare night-time (asleep) blood pressure (BP) evaluated by home monitoring (HBPM) vs. ambulatory monitoring (ABPM) in adolescents and young adults with diabetes type-1 (DM1) and examine their association with indices of preclinical target organ damage (TOD).

Design and method:

Individuals aged 12–30 years with DM1 were subjected to 24-hour ABPM (every 20 min, Microlife WatchBP O3) and 7-day HBPM (daytime: duplicate morning and evening measurements; night-time: 3 measurements per night for 3 nights; Microlife WatchBP Home-N), as well as TOD assessment (left ventricular mass index, carotid intima media thickness, urine albumin excretion).

Results:

Data from 24 individuals were analysed (mean age 19.8 ± 5.3 [SD] years, men 62.5%, BMI 25.6 ± 4.1 kg/m2, 13% with elevated 24-hour ABPM]. The number of valid ABPM readings was 45.7 ± 1.4/22.4 ± 4.8 (awake/asleep, mean ± SD) and HBPM 26.3 ± 2.1/8.3 ± 2.0 respectively (p < 0.001/ < 0.001). Daytime HBPM was lower than ABPM (by 2.7 ± 0.1/1.9 ± 0.7 mmHg, systolic/diastolic, p < 0.05/ < 0.05), but night-time was higher (difference 5.0 ± 0.6/3.2 ± 0 mmHg, p < 0.01/ < 0.05). There was a strong association between HBPM and ABPM (daytime r = 0.85/0.88, night-time r = 0.68/0.49, systolic/diastolic). There was fair agreement (88%; kappa = 0.33) between ABPM and HBPM in diagnosing nocturnal hypertension (age > = 16 years > = 120/70 mmHg; < 16 years > = 95th centile;) and poor agreement in detecting non-dippers (38%, kappa = 0.032). No significant association of night-time ABPM or HBPM and indices of TOD was found, probably due to small sample size and low prevalence of TOD.

Conclusions:

These preliminary data in young individuals with DM1 show that nocturnal HBPM is feasible and provides values similar to ABPM. Further research is needed to extend these finding and investigate their clinical relevance in DM1.
REAL WORLD IMPACT OF BLOOD PRESSURE CHANGES ON MORBIDITY AND MORTALITY IN TYPE 2 DIABETES
Authors: Martinez Fernando , Calderon Jose Miguel , Sauri Inmaculada , Fernandez Antonio , Diaz Javier , Bea Carlos , Redon Josep
Published: June 2022

Objective:

To assess the impact of BP changes on the risk of cardiovascular events and mortality in type 2 diabetes.

Design and method:

The sample was selected using the HER of the Valencian Community. Type 2 diabetics were selected through ICD codes and retrospectively evaluated from January 2012 to December 2016. To evaluate BP changes, the follow-up time was divided in six-month blocks and the average of BP for each interval was considered. SBP was categorized: < 120 mmHg; 120–129 mmHg (reference); 130–139 mmHg; 140–149 mmHg; > 150 mmHg. To evaluate the influence of DBP, the population was stratified according to categories of average DBP: < 60 mmHg; 60–69 mmHg; 70–79 mmHg; > 80 mmHg. Information about cardiovascular events, including Stroke and Acute Coronary Syndrome (ACS) was extracted from the ICD codes. Total mortality was determined by matching records and death certificates. Time-varying Cox regression for SBP stratified by DBP categories was used to assess the risk associated with changes of SBP. The models were adjusted by age, sex, HBA1c, KDIGO, previous cardiovascular events and use of cardiovascular drugs.

Results:

156 363 type 2 diabetics patients were included (mean age 69.5(11.5), 48.7% females, mean glycated Hb 7.05 (1.35%) 21% in secondary prevention, 21.4% under insulin treatment). The average number of BP measurements was 14. During an average follow-up of 4.18 y, there were 13399 deaths, 15100 strokes and 6295 ACS. In the fully adjusted time-varying Cox regression, having a SBP< 120 mmHg was a significant risk factor for death across all categories of DBP, whereas SBP> 130 mmHg conferred protection. For the case of ACS and stroke, a J-curve phenomenon was observed with significantly higher risk for those with SBP> 150 mmHg or < 120 mmHg across categories with DBP> 60 mmHg. This J-curve phenomenon was also observed graphically using restricted cubic splines (Figure).

Conclusions:

Although difficult to achieve in clinical practice, lower boundaries for BP goals in diabetics have to be taking into account.
META-ANALYSIS ASSESSING THE IMPACT OF PRIOR HEART FAILURE AND CHRONIC KIDNEY DISEASE ON THE CARDIOVASCULAR EFFICACY OF GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS
Authors: Patoulias Dimitrios , Katsimardou Alexandra , Zografou Ioanna , Kefas Aristides , Toumpourleka Maria , Boulmpou Aristi , Kassimis George , Papadopoulos Christodoulos , Doumas Michael
Published: June 2022

Objective:

Chronic kidney disease (CKD) and heart failure (HF) represent common co-morbidities in patients with type 2 diabetes mellitus (T2DM), constituting an additional burden that boosts overall morbidity and mortality. Therefore, we sought to determine whether history of HF or CKD affects the cardiovascular efficacy of GLP-1RAs, also utilizing data from the recently published FREEDOM Cardiovascular Outcomes Trial, which evaluated the cardiovascular safety of delivering a continuous subcutaneous infusion of the GLP-1RA exenatide (ITCA 650) in T2DM.

Design and method:

We searched the relevant, hallmark, cardiovascular outcome trials of GLP-1RAs in T2DM. We set as primary efficacy outcome the effect of GLP-1RAs versus placebo on the risk for a major adverse cardiovascular event (MACE) according to the prior history of HF, while we also assessed as a secondary efficacy outcome the effect of GLP-1RAs on the risk for MACE according to a prior diagnosis of CKD.

Results:

We finally pooled data from 4 trials for a total of 26,272 enrolled participants with T2DM. Regarding the primary efficacy outcome, we demonstrated that GLP-1RAs versus placebo resulted in a significant decrease by 14% (RR = 0.86, 95% CI; 0.76 – 0.97, I2 = 50%), regardless of history of HF (p-value for subgroup differences = 0.88). Concerning the secondary efficacy outcome, we showed that GLP-1RA treatment was superior to placebo in reducing the risk for a MACE (RR = 0.87, 95% CI; 0.75 – 1.02, I2 = 70%), while prior status of CKD did not affect the generated results (p-value for subgroup differences = 1.00).

Conclusions:

GLP-1RAs seem to constitute a safe and efficacious treatment option in patients with T2DM and established or at high risk for atherosclerotic cardiovascular disease, while HF or CKD status at baseline do not substantially affect the observed cardio-protective effect against hard cardiovascular endpoints.
META-ANALYSIS ADDRESSING THE EFFECT OF SODIUM-GLUCOSE CO-TRANSPORTER-2 INHIBITORS ON FLOW-MEDIATED DILATION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Authors: Patoulias Dimitrios , Siskos Fotios , Katsimardou Alexandra , Imprialos Konstantinos , Koutsampasopoulos Konstantinos , Stavropoulos Konstantinos , Zografou Ioanna , Kefas Aristides , Papadopoulos Christodoulos , Doumas Michael
Published: June 2022

Objective:

Endothelial dysfunction seems to play a pivotal role in the pathogenesis of cardiovascular disease and related complications among high-risk patients, such as those suffering from type 2 diabetes mellitus (T2DM). Non-invasive peripheral endothelial function assessment with measurement of brachial artery flow-mediated dilation (FMD) has been demonstrated to predict adverse cardiovascular events. Herein, we sought to determine whether SGLT-2 inhibitors provide a significant effect on endothelial function, as assessed through FMD.

Design and method:

We searched PubMed, Cochrane Library and grey literature from inception to 10th October 2021 for parallel group randomized controlled trials (RCTs) enrolling adult subjects with T2DM, assigned to a SGLT-2 inhibitor versus placebo or active comparator and addressing their effect on FMD. We set as primary efficacy outcome the change in FMD with SGLT-2 inhibitor versus control.

Results:

We pooled data from 4 trials in a total of 270 subjects with T2DM. We demonstrated that treatment with SGLT-2 inhibitor versus placebo or active comparator produced a significant increase in FMD by 1.66% (95% CI; 0.56 – 2.76, I2 = 28%, p = 0.003). Notably, all eligible RCTs utilized dapagliflozin. Overall risk of bias was evaluated as low across the selected studies.

Conclusions:

The present meta-analysis demonstrated a clear benefit on endothelial function with SGLT-2 inhibitors compared to placebo or active comparator. Although the sample size is small, it seems that amelioration of endothelial dysfunction with SGLT-2 inhibitors constitutes another significant mechanism that confers to cardio-protection with this drug class. Larger RCTs will shed further light on this important pathophysiologic link.
PREDICTORS OF CHRONIC HEART FAILURE WITH PRESERVED EJECTION FRACTION IN PATIENTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH EMPAGLIFLOZIN
Authors: Lebedev Denis , Lyasnikova Elena , Vasilyeva Elena , Sitnikova Maria , Babenko Alina
Published: June 2022

Objective:

Currently, it’s not well known what factors influenced the incidence of heart failure with preserved ejection (HFpEF) fraction in patients receiving sodium glucose co-transporter 2 inhibitors (SGLT2i).

Objective:

To evaluate predictors of HFpEF in patients with type 2 diabetes mellitus (T2DM) receiving SGLT2i

Design and method:

It was a prospective study in patients with T2DM. Inclusion criteria were: male and female, age 40–65 years, T2DM with duration at least for 1 year, absence of established atherosclerotic cardiovascular disease and HF. Exclusion criteria were: type 1 diabetes mellitus, glycated hemoglobin (HbA1c)> 11% at screening, insulin therapy, atrial fibrillation, clinically significant valvular heart disease, chronic kidney disease, other serious conditions that would make the patient unsuitable for participation in the study. Clinical, laboratory (including biomarkers such as NT-proBNP, sST2, galectin-3, PICP,PIIINP,MMP-9,TIMP-1) and instrumental (echocardiography) data were collected at baseline. Empagliflozin 10 mg daily was prescribed for all patients. After 3 years of follow-up, information about HF events (hospitalization for HF, established HF in outpatient department by cardiologist), other clinically important data were obtained.

Results:

Seventy-five patients were included in the study. The mean age was 58 (47.9;65.1) years, 45,1% were female. Most patients had T2DM for more than 4 years. Mean HbA1c was 8.6% (7.6;9.5), all patients received oral antihyperglycemic medications. After 3 years of follow-up HFpEF was established in 16 patients. The HF group had higher waist circumference values, higher Nt-proBNP, galectin-3 and P1CP levels at baseline than patients without HF (all p < 0.05). The threshold for galectin-3 level associated with increased risk of HFpEF in this population was 10.3 ng/ml (AUC area = 0.86; sensitivity, 87%; and specificity, 73%; p < 0.001). Multiple logistic regression analysis identified significant risk factors for new onset of HFpEF: age> 60 years, diabetes duration> 10 years and presence of abdominal obesity were independent predictors of HFpEF. Galectin-3 level > 10 ng/ml was associated with increased risk of HF incidence (OR = 2.15; 95% CI, 1.80–5.21; p = 0.01).

Conclusions:

Predictors for incidence HFpEF in patients with T2DM were age, diabetes duration, presence of abdominal obesity and galectin-3 levels higher than 10 ng/ml.
APPLICABILITY OF THE SOUTH AFRICAN DIABETES PREVENTION PROGRAMME IN THE EASTERN CAPE PROVINCE OF SOUTH AFRICA: A STUDY PROTOCOL
Authors: Hill Jillian , Yako Yandiswa , Rusike Constance , Toni Simthandile , Musarurwa Hannibal , Kengne Andre Pascal
Published: June 2022

Objective:

South Africa (SA) is currently home to almost 14% of the estimated 19 million people living with diabetes in Sub-Saharan Africa (SSA). Urgent efforts are needed both to diagnose and appropriately manage South Africans with diabetes, as well as to prevent the progression to diabetes among those at high risk. While, there is definitive evidence on the effectiveness of lifestyle interventions in preventing the progression of diabetes among high risk people in high income countries, little is known about appropriate intervention approaches to be used in SA (within all nine provinces) and other SSA countries. The South African Diabetes Prevention Programme (SA-DPP) was initiated to generate such evidence for SA and inform similar initiatives in other countries in the region. The goal of the SA-DPP is to prevent or delay the occurrence of diabetes among high risk South Africans, with benefits extending to other major cardiometabolic risk factors that share behavioural determinants with T2DM.

The purpose of this project is to implement and evaluate the suitability and applicability of the SA-DPP developed and tailored in urban populations in the Western Cape Province, in peri-urban populations in the Eastern Cape Province of South Africa.

Design and method:

We propose to implement and evaluate a DPP that has been adapted for SA, which was based on interventions previously shown to be effective in Finland and Australia. The SA-DPP trial is in its intermediate phases in Cape Town. We will use an open-labelled cluster randomized control design, with optional implementation of the intervention in the control clusters at the end of the study. 24 clusters across peri-urban communities in OR Tambo, Eastern Cape will be randomly allocated to participate in a lifestyle intervention facilitated by teams of non-professional health workers.

Results:

NA.

Conclusions:

Programme success will be assessed by comparing at 12-months participants in clusters receiving the intervention and those in the clusters not yet receiving the intervention for changes in: 1) body weight; 2) blood glucose, lipids, blood pressure, insulin sensitivity, diabetes risk score, albuminuria; 3) and incident diabetes; 4) safety and participant satisfaction. 4) Economic impact.
DEVELOPMENT OF TEXT-MESSAGING TO SUPPORT THE SOUTH AFRICAN DIABETES PREVENTION PROGRAM
Authors: Hill Jillian , Faber Mieke , De Villiers Anniza , Mulabisano Tshavhuyo , Mostert Sonja , Kotze Liske , Kengne Andre P.
Published: June 2022

Objective:

Emerging evidence suggests that the addition of text-messaging to standard healthy lifestyle interventions may improve the outcomes of diabetes prevention programs (DPP). This paper describes the process of developing text-messages for people at risk of developing diabetes in low-resourced communities as part of the South African DPP (SA-DPP).

Design and method:

The development comprised multiple steps which included nutrition and physical activity experts, who were guided by recommended steps for developing and pre-testing text messaging for health behavior change. The steps included: 1) Message development: 44 nutrition messages and 23 exercise messages were formulated based on the existing SA-DPP curriculum and its formative research; 2) these text messages were evaluated for readability/understandability in terms of content, language, and quality of information through interviews [structured questionnaire conducted telephonically or in-person] with 75 participants from two low-resourced areas; 3) messages not well understood according to the interviews were refined by the expert panel; 4) participants from step 2 who showed the least understanding of the messages participated in three workshops to evaluate the refined text-messages; and 5) the text bank was finalized.

Results:

Based on the results of the readability survey, 37 of the 69 formulated text messages [24 of the 44 encouraging healthy eating, and 13 of the 23 promoting physical activity] were refined by the expert panel. Focused discussions revealed that participants still had some difficulties with terms such as “variety’’ and “diet’’, and the concept of avoiding certain foods e.g. sugar, sweets, chocolates and salty snacks and eating a “fresh’’ salad with a meal. Thus, a further seven messages were refined considering alternate terminology proposed by the participants. The final text bank includes a total of 67 messages; topics covered are on fruit, vegetables and variety in the diet (n = 15), limiting fat intake (n = 10), avoiding sugar (n = 11), avoiding salt (n = 5), promoting fibre-rich foods (n = 1), messages promoting physical activity (n = 21) and general check-in messages (n = 4).

Conclusions:

This paper outlines the evidenced-based and participatory process of developing understandable healthy lifestyle text messages to promote and maintain behavior change objectives of participants at risk for developing diabetes.
ASSOCIATION BETWEEN THE TIME OF EVOLUTION AND LIFESTYLES WITH ADHERENCE TO TREATMENT FOR DIABETES MELLITUS. BARRANQUILLA COLOMBIA
Authors: Rodero Eulalia Maria Amador , Esmeral Leslie Piedad Montealegre , Mogollon Luis Guillermo Rivera , Charris Martha Arteta , de Oro Aguado Carlos , Rebolledo Roberto , Iriarte Tammy
Published: June 2022

Objective:

The objective of this work was to establish whether the time of evolution and lifestyles were associated with adherence to treatment in a group of patients.

Design and method:

A cross-sectional analytical descriptive study was obtained using simple random sampling, a sample of 272 patients was obtained, of which 63% were female, average age of 55 years and average evolution time 7.5 years. The information was obtained using the treatment adherence questionnaire for cases of arterial hypertension factor II (Varela) modified for diabetics with a Cronbach alpha of 0.86. Data were processed with STATGRAPHIC Centurion 18 software and the R statistic. Hypotheses were tested with Wilcoxon rank test for evolution time and chi square test for lifestyles.

Results:

With a p-value < 0.05 for evolution time and the dimensions of the lifestyles studied: eating habits, practice of physical activity, it is concluded that adherence to diabetes treatments is associated with the time of evolution and with the practice of healthy lifestyles related to food and practice of physical activity.

Conclusions:

Adherence to treatments in patients with diabetes is associated with the time of evolution and the practice of good lifestyles. These two factors can be taken as predictors, which is why it must be rigorously monitored by health authorities
HOME BLOOD PRESSURE MEASUREMENT AND E-HEALTH DURING PREGNANCY: PRACTICE AND EXPERIENCE WITH THE HY-RESULT SYSTEM
Authors: Postel-Vinay Nicolas , Shao Jiali-Delphine , Gebara Nicole , Pinto Anne , Servais Aude , Amar Laurence
Published: June 2022

Objective:

To evaluate the practice and the experience of pregnant women using the Hy-Result app.

Design and method:

Descriptive, multicentric study conducted in France Overall, 10 centers were included (5 maternity units, 2 ESH excellence hypertension centers, 1 primary care center, 2 patients’ associations network). Women were asked to measure the BP, use the app, share their report to the investigator and reply to on-line questionnaires (Q1, Q2, Q 3).

Results:

Among the 107 women included in the study, 82 (77%) responded after using successfully the Hy-Result system. Among them, 72 participants shared to the investigator their PDF report by email. Of these, 95% declared the software was easy or very easy to use; 93% believe the software helps them better monitor their BP; 94% that the color code classification was clear; 93 % affirmed that the app helped them when consulting their physician for their BP evaluation. Majority (87%) perceived the software to be reliable. Furthermore, 87 % said they trust the system and 62 % declared that performing HBPM and self-interpret their readings was reassuring whereas 7% felt that is was a concern. Out of the 72 e-mailed Hy-Result PDF report, 83% measured their BP 3 times in the morning, 3 times in the evening, for at least 3 days as recommended by ESH guidelines. Sixty-four women answered to Q3 after giving birth. Among them, 75% shared their BP reports with their doctor or midwife (even when their measurements were in the Green; 8% only when their measurements were in the Orange or Red). After delivery, 48% women continue to self-monitor their BP, half of them upon their physician’s request and the others by their own initiative). When analyzing the responses to Q 2, we found that 68% women declared that the software helps me talk to my doctor or midwife about my BP readings.

Conclusions:

HBPM with self-interpretation of the BP readings using the Hy-Result software is feasible during pregnancy. The use of this coaching app by pregnant women may be recommended in common practice by healthcare professionals and patient associations.
DEVICE-GUIDED SLOW BREATHING WITH DIRECT BIOFEEDBACK OF PULSE WAVE VELOCITY – EFFECTS ON PULSE ARRIVAL TIME AND SELF-MEASURED BLOOD PRESSURE IN PATIENTS WITH HIGH NORMAL BLOOD PRESSURE
Authors: Mengden Thomas , Sehnert Walter , Bachler Martin , Wassertheurer Sigfried
Published: June 2022

Objective:

There is evidence that device guided slow breathing using biofeedback acutely reduces blood pressure (BP) and pulse wave velocity (i.e., increases pulse arrival time) from own prior studies and from the literature. The objectives of the study presented here were to test whether the results of changes observed in pulse arrival time in earlier studies are reproducible over one week and how changes in pulse wave velocity/pulse arrival time translate into absolute blood pressure changes.

Design and method:

Patients with a systolic BP 130–160 mmHg or treated essential hypertension (21 females / 23 males) were trained to perform repeated and unattended device guided slow breathing exercises over 5 days. A simple device was used to measure pulse arrival time by electrocardiography and photoplethysmography connected with a smartphone or tablet to provide biofeedback. Furthermore, they were skilled to perform a self-measurement of blood pressure before and after the breathing exercise using a validated upper-arm device. The mean of 3 consecutive self-measured readings was used before and after each breathing exercise.

Results:

Office BP at screening (Median [1.,3. Q]) was 137 [132,142] / 83 [79,87] mmHg. We observed an average increase of pulse arrival time (PAT) of 6ms (p < 0.05, SD 13ms) during the breathing exercise. This increase in PAT during slow breathing was accompagnied by a delayed arrival of the first pulse wave maximum and a prolonged ejection time. The increase in PAT was associated with a significant reduction of self-measured systolic blood pressure of 5 mmHg (p < 0.01, SD 8 mmHg) and beyond 6 mmHg (p < 0.01, SD 9 mmHg) of white coat effect. Data furthermore demonstrated that these changes were highly reproducible over one week

Conclusions:

The results of this work confirmed earlier findings from a pilot trial that a simple method for device guided slow breathing and biofeedback leads to favorable changes (increase) in pulse arrival time and systolic blood pressure (decrease) and therefore warrants future use of this method. Furthermore, the decrease in blood pressure was probably generated via vasodilation as shown by the wave shape parameters
SIMPLIFIED REGIMEN FOR THE MANAGEMENT OF HYPERTENSION WITH TELEMEDICINE AND BLOOD PRESSURE SELF-MONITORING (SIMPLE): STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL
Authors: Maimaitiaili Rusitanmujiang , Li Yao , Zhang Yi , Feng Tienan , Xu Yawei , Yang Haotian , Zhang Ji , Wang Mingliang , Fang Zhao , Gao Junqing , Hu Jun , Jiang Chenghua , Zhao Yifan
Published: June 2022

Objective:

Telemedicine and blood pressure (BP) self-monitoring conduces to management of hypertension. Recent hypertension guidelines highly recommended single-pill-combination (SPC) for the initial treatment of essential hypertension. Based on this fact, an SPC-based telemedicine titration regimen with BP self-monitoring could be a better way in managing hypertension. This trial aims to elucidate whether telemedicine combined with BP self-monitoring is superior to self-monitoring alone during hypertension management.

Design and method:

This study will be a multi-centered, open-labelled, randomized controlled trial. A minimum sample of 358 hypertensive patients with uncontrolled BP from four centers will be included. The intervention group will include BP self-monitoring and tele-monitoring plus a free SPC-based telemedicine titration therapy for 6 months, they will be recommended to take BP measurements at least once every seven days, in the meantime, researchers will call to give a consultation on lifestyle or titration advice once a fortnight. The control group will be required to self-monitor BP at the same time interval as intervention group, without any therapy change. Primary outcome of the trial will be the difference in SBP at 6-month follow-up between intervention and control group, adjusted for baseline variables. Secondary outcomes such as BP control rate, major adverse cardiovascular events, medication adherence, quality of life will be investigated.

Results:

Ongoing study, no further results to share at this time.

Conclusions:

Ongoing study, no further results to share at this time.
EVALUATION OF A DIGITAL THERAPY FOR UNCONTROLLED HYPERTENSIVE PATIENTS FOLLOWED BY GENERAL PRACTITIONERS IN FRANCE
Authors: Girerd Xavier , Canipel Lydie , Hanon Olivier , Pathak Atul , Boualit Robert , Mallion Jena Michel
Published: June 2022

Objective:

The digital therapy was designed by hypertension specialists and included

-  a touch-sensitive tablet (Vodafon smart tab 3G) and an automatic blood pressure, connected via Bluetooth to the tablet (ihealth, BKN-550BT), a web portal developed specifically for the study with access reserved for health professionals involved in the follow-up of hypertensive patients. The health data were hosted on an accredited server.

Design and method:

The digital therapy was designed by hypertension specialists and included

-  a touch-sensitive tablet (Vodafon smart tab 3G) and an automatic blood pressure, connected via Bluetooth to the tablet (ihealth, BKN-550BT), a web portal developed specifically for the study with access reserved for health professionals involved in the follow-up of hypertensive patients. The health data were hosted on an accredited server.

-  as software for the patient, several applications specifically developed to 1) perform home blood pressure monitoring over 3 days 2) monitor treatment compliance (GIRERD questionnaire) 3) detect excessive salt consumption (ExSel questionnaire)

for the physician a web interface specifically developed to 1) know the results of the remote monitoring of each patient 2) help to follow the recommendations of the ESH for the associations of antihypertensive drugs 3) obtain if necessary the opinion of a Hypertension specialist after a request written by e-mail.

77 patients treated for uncontrolled primary hypertension at office visit despite the prescription of bi-therapy were randomized into 2 groups: a group in which the physician had access to functions 2 and 3 of the website, and a control group in which the physician did not have access to functions 2 and 3 of the website. All patients were instructed to use the 1 2 3 applications once every 3 weeks for a total of 3 months.

Results:

The patients included were 63 ± 7 years old. 32.5% of patients used the entire program and completed 4 HBPM and visited the physician again at the final visit. The table shows the main results by randomization group:

Conclusions:

A digital therapy developed by hypertension specialists is effective in improving hypertension control in patients followed by general practitioners in France.