bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.
HOME BLOOD PRESSURE MONITORING WITH A DIGITAL BLOOD PRESSURE COACH - A PROSPECTIVE ANALYSIS OF USER DATAi
Authors: Beger Christian , Lenz Anna , Wagner Steffen , Filler Andreas , Sévin Claire-Michelle , Heppler Michelle , Volland Dirk , Limbourg Florian 
Published: June 2022

Objective:
Home blood pressure monitoring (HBPM) is recommended by guidelines for the management of hypertension. The Manoa smart phone app is a certified digital coach that informs, guides and supports users in guideline-compliant HBPM, which involves completion of at least 6 days of home BP measurements. The app has been freely available in all relevant app stores since April 2020.

Design and method:
From 4/20 to 3/21 we prospectively analyzed self-reported BP levels and user data from users who self-identified as having the diagnosis of hypertension. The prospective study protocol was approved by the local ethics committee.

Results:
To evaluate the effects of a digital BP coach on BP levels we analyzed the change in app-documented BP levels between baseline and follow-up HBPM periods (8–16 weeks, n = 864). Average baseline systolic home BP was 131.5 mmHg for the total group, which decreased significantly to 128.06 mmHg at follow-up (p < 0.05), resulting increased BP control from 70% of hypertensive users at baseline to 81% at the follow-up HBPM period. In the subgroup of users with uncontrolled BP at baseline, and who also had recorded follow-up BP data (n = 384), baseline BP was 138.8.0mmHg, which decreased significantly to 132.69 (p < 0.001).
We analyzed the change in SBP according to baseline SBP. To this end, we first used non-linear fitting followed by steady linear fitting and linear regression analysis. There was a significant negative linear correlation (r = -0.56, p < 0.001) between SBP lowering and baseline BP down to level of SBP of 125 mm Hg. Below this value, baseline SBP was not associated with SBP decrease at follow up (r = -0.19, p = 0.16).

Conclusions:
Our data show that the use of a digital BP coach by users with self-reported hypertension is associated with a reduction in average BP and an improvement in hypertension control after two periods of structured HBPM.
EFFECTS OF MINERALOCORTICOID RECEPTOR ANTAGONISTS ON ALDOSTERONE TO RENIN RATIO IN PATIENTS WITH PRIMARY ALDOSTERONISM
Authors: Pecori Alessio , Buffolo Fabrizio , Burrello Jacopo , Mengozzi Giulio , Rumbolo Francesca , Avataneo Valeria , D’Avolio Antonio , Rabbia Franco , Bertello Chiara , Veglio Franco , Mulatero Paolo , Monticone Silvia 
Published: June 2022

Objective:
Current guidelines recommend to withdraw interfering antihypertensive drugs before to perform a screening test for primary aldosteronism (PA). Recent studies suggested that diagnostic work-up of PA might be performed without withdrawing mineralocorticoid receptor antagonist (MRA) treatment in selected patients, especially when severe hypertension and hypokalemia are difficult to control.
We designed a prospective study to evaluate the effects of MRA treatment on aldosterone to renin ratio (ARR) in patients with PA.

Design and method:
We prospectively recruited 121 patients with confirmed PA and started on canrenone treatment. Eighteen patients were enrolled in a short-term treatment cohort to assess the effects of MRA on aldosterone to renin ratio (ARR) and potassium after 2 and 8 weeks of canrenone therapy. One hundred and two patients were recruited in the long-term treatment cohort to evaluate the effects of canrenone on ARR after 2 to 12 months of MRA therapy.

Results:
Plasma renin activity and potassium displayed a significant increase, and ARR showed a significant reduction compared with baseline in patients with PA after MRA initiation. These effects were observed both after a short- and a long-term treatment with canrenone, and were progressively more significant after longer periods of therapy and with greater doses of MRA. We demonstrated that canrenone assumption severely impacts on the rate of false-negative screening tests for PA, which raised from 16.7% to 72.5% after 2 weeks and 7–12 months of MRA treatment, respectively.

Conclusions:
ARR testing for PA screening should not be performed under MRA therapy.