bluuebunny/crossref_metadata_2025_split huggingface dataset:
MULTIMEDIA FOR DELIVERING PARTICIPANT INFORMED CONSENT IN CARDIOVASCULAR TRIALS
Authors: Chapman Niamh , Mcwhirter Rebekah , Armstrong Matthew , Fonseca Ricardo , Campbell Julie , Nelson Mark , Schultz Martin , Sharman James 
Published: April 2021

Objective:
Obtaining informed consent is a cornerstone requirement of conducting ethical research. Traditional paper-based consent is often excessively lengthy, legalistic in character, and may fail to achieve desired participant understanding of study requirements. Multimedia tools including video and audio may be a useful alternative. This study aimed to determine the efficacy, usability and acceptability of stand-alone multimedia delivery of participant consent relating to a cardiovascular trial.

Design and method:
A total of 298 participants (63 ± 8 years; 51% female) were randomised to delivery of cardiovascular research study information and signed consent via multimedia (intervention; n = 146) compared with standard paper-based approach (control; n = 152) in a clinical research setting. Intervention was free of research staff and included short audio-visual explanations, with computer-based finger-signed consent. Efficacy, usability and acceptability were assessed by questionnaire.

Results:
All participants successfully completed allocated interventions. Efficacy parameters were significantly higher among intervention participants, including better understanding of study requirements compared with controls (P < 0.05 all). Intervention participants were also significantly more likely to engage with the study information and spend more time on the consent process and study questionnaire (P = 0.038 and P = 0.007, respectively). Both groups reported similar levels of acceptability of the consent process, although more control participants reported that the study information was too long (24% versus 14%; P = 0.020).

Conclusions:
A standalone multimedia consent process is effective for achieving participant understanding and obtaining consent on cardiovascular research in a clinical research setting free of research staff. Thus, multimedia represents a viable method to reduce the burden on researchers, meet participant needs, and achieve informed consent in clinical cardiovascular research.
COST-EFFECTIVENESS ANALYSIS FOR THE USE OF INTERVENTIONAL DECENTRALIZED TELEMONITORING (IDTM) IN HYPERTENSION THERAPY
Authors: Schmieschek Sebastian , Neumann Claas Lennart , Schulz Egbert G. 
Published: April 2021

Objective:
We calculate quality-adjusted life years (QALY) and incremental cost-effectiveness ratio (ICER) for the use of interventional decentralized telemonitoring (idTM) in hypertension therapy. Both values are key performance indicators for cost-benefit and cost-effectiveness analysis of medical interventions.
The calculations compare blood pressure adjustment and the correlated reduction in risk of morbidity and mortality between idTM and standard therapy (ST).
Prior studies have shown idTM to significantly reduce the time required to reach blood pressure targets as well as to reduce the variability of blood pressure values. IdTM also allows maintaining blood pressure on target for a longer duration than ST.

Design and method:
Our QALY evaluation only takes myocardial infarction (MI) and stroke, the two most prominent comorbidities of hypertension, into account. Thus, the achievable QALY are likely to be underestimated by this analysis. We assume a linear correlation between elevated blood pressure and the risk of morbidity and mortality. Data on prevalence and morbidity have been included from statistical and medical publications on the German population while data on life quality come from an EQ-5D-based study performed in the US.

Results:
We calculate the ICER for both for the difference in QALY and blood pressure reduction in mmHg. The latter allows evaluating the cost-effectiveness of idTM independent of specific comorbidities.

Conclusions:
Even though idTM adds cost to the treatment of hypertension, we find that the resulting improvement of blood pressure significantly improves QALY and ICER over ST. Therefore, idTM in hypertension therapy is a promising concept both from a medical and cost-effectiveness point of view. Especially in the context of the upcoming evaluation of digital health applications (DiGA) by the German Federal Institute for Drugs and Medical Devices (BfArM), this is a crucial result. Furthermore, the results suggest idTM as a sensible candidate for addition as an element of standard care in Germany.
PRECISE PREDICTION OF BLOOD PRESSURE LEVELS AFTER CONTROLLING FOR SEASONAL TEMPERATURE: A THREE-YEAR PROSPECTIVE COHORT OF ELDERLY POPULATION IN HONG KONG
Authors: Tsoi Kelvin Kf , Li Jinhui , Xue Jiashu , Yiu Karen Kl , Lee Eric Kp , Wong Samuel Ys 
Published: April 2021

Objective:
Cardiovascular disease risk has been linked to the environmental temperature changes, but few studies have evaluated the long-term temperature impacts on the blood pressure (BP) projection.

Design and method:
Regular blood pressure records were uploaded to the data servers from elderly community centres in Hong Kong since 2016. Meteorological data were obtained from the Hong Kong observatory. The Vector Autoregressions, the most common deep learning method was adopted for systolic BP (SBP) projection. Temperature and diastolic BP (DBP) were controlled in the model. The predictions of SBP were compared with the real BP records in the last 6-month and 12-month. The mean absolute percentage error (MAPE) and the mean absolute deviation in terms of mmHg were used to describe the accuracy of prediction. Subgroup analyses were also conducted based on age, gender, social-economic status (SES), drug intake level, and medical diseases (diabetes & hypertension).

Results:
A total of 733 participants regularly measured BP over three years since 2016. Most of them (67.7%) were aged over 75 years and the majority are female (73.8%). The MAPE of the projection models were 1.8% for 6-month and 1.9% for 12-month BP projections. The mean absolute SBP value in the 6-month projection model was 1.66mmHg with the 95%CI range of 2.3319mmHg. between the projection model and real SBP records. Moreover, the temperature increment of one unit in degree Celsius was associated with a 0.597 mmHg increased in SBP. The temperature effect on BP was more prominent for the participants with hypertension. Subpopulation analysis showed that the impact of gender (p = 0.005) and hypertension status (p = 0.0416) had more significant impacts on the blood pressure projection among the elderly participants.

Conclusions:
Seasonal temperature showed as a critical factor for the evaluation of hypertension. Understanding the blood pressure readings after removal of seasonal temperatures will help for a better diagnosis.
EFFECT OF L- AND N-TYPE CALCIUM CHANNEL BLOCKER CILNIDIPINE ON SERUM SOLUBLE (PRO)RENIN RECEPTOR CONCENTRATION
Authors: Watanabe Daisuke , Morimot Satoshi , Ichihara Atsuhiro 
Published: April 2021

Objective:
Cilnidipine (Cil) is an L- and N-type calcium channel blocker that inhibits the release of norepinephrine (NE) from the sympathetic nerve endings. It has inhibitory effects on SNA and the renin-angiotensin-aldosterone system (RAAS), as well as its strong renal and vascular protective effects. (Pro)renin receptor [(P)RR] activates the tissue RAAS and contributes to the pathogenesis of organ damages. The soluble form of (P)RR [s(P)RR] is produced via cleavage of (P)RR, and its blood concentration is a biomarker of organ damage. The present study investigated the effects of Cil on serum s(P)RR concentration, as well as the relationships between the serum s(P)RR concentration and changes in NE and aldosterone (ALDO) levels.

Design and method:
Patients with essential hypertension were randomly assigned to 2 groups: the Cil treatment (C) group (n = 19) and the amlodipine treatment (A) group (18). Changes in various parameters (urinary, biochemistry, and endocrine data and cardio-ankle vascular index (CAVI), an index of arterial stiffness, during the 6 months-treatment period were compared.

Results:
In both groups, there was a significant decrease in blood pressure by the treatments, while there was no difference in changes in blood pressure between the two groups. In the C group, urinary albumin excretion and CAVI decreased significantly. There were no changes in s(P)RR levels in both groups. Serum NE levels (rate of decline: 13.6 ± 33.3%) and ALDO levels (18.4 ± 33.6%) significantly decreased in the C group. In the C group, while the decline rate of NE was significantly greater in the low s(P)RR group (24.6 ± 31.4%, n = 9) than in the high s(P)RR group (1.2 ± 33.0%, n = 10), changes in ALDO was not significantly different between the groups.

Conclusions:
The present study reconfirmed that Cil reduces NE and ALDO levels, and has renal and vascular protective effects. Although changes in serum s(P)RR concentration by Cil were not demonstrated, there was an association between the serum s(P)RR levels and the rate of decline of NE, suggesting involvement of (P)RR expression in the regulation of SNA. Future studies are needed to determine the underlying mechanism of this involvement.
CLINICAL AND BIOCHEMICAL OUTCOMES AFTER RADIOFREQUENCY ABLATION FOR ALDOSTERONE-PRODUCING ADENOMA AT KEIO UNIVERSITY HOSPITAL - 2020 ANNUAL REPORT
Authors: Kozuma Takahide , Kurihara Isao , Kobayashi Sakiko , Yokota Kenichi , Miyashita Kazutoshi , Kohata Nao , Takase Kei , Nakatsuka Seishi , Itoh Hiroshi 
Published: April 2021

Objective:
Total adrenalectomy of affected adrenal is the standard therapy for aldosterone-producing adenoma (APA), which is a curable subtype of primary aldosteronism (PA). However, there are cases in which total adrenalectomy could not be performed because of bilateral adenomas or incapability of operation under general anesthesia. For these cases radiofrequency ablation (RFA), which is minimally invasive and enables cortical-sparing treatment, could be a choice of treatment. A multicenter clinical trial of RFA for APA was performed in Japan from 2015 to 2016. The long-term efficacy of this treatment remains to be established, so we have assessed its effectiveness and safety annually and reported it at ISH 2018. The evaluation of clinical and biochemical outcomes has been extended. This time we report these outcomes 4 years after treatment.

Design and method:
The long-term efficacy of RFA for APA was monitored and analyzed.

Results:
10 cases of APA were treated with RFA between June 2015 and March 2016. 7 cases were in valid follow-up at the end of November 2019. Aldosterone-renin ratio (ARR) returned to normal in all 7 cases. Hypertension was not cured in 2 cases (29%) though ARR were normal. Urinary albumin levels were improved in all cases. Follow-up CT images showed that the tumor vanished in 1 case (14%), shrank in 3 cases (43%) and unchanged in 3 cases (43%). There were no cases indicating adrenal insufficiency after RFA.

Conclusions:
In average 4-year follow-up after RFA, there were no cases suggesting recurrence. RFA for APA appears to be effective and safe.
THE CHARACTERISTICS OF PATIENTS SENSITIVE TO MINERALOCORTICOID RECEPTOR ANTAGONISTS
Authors: Kidoguchi Satoshi , Sugano Naoki , Takahashi Daisuke , Yokoo Takashi 
Published: April 2021

Objective:
Primary aldosteronism (PA) is related to various cardiovascular events, thus the treatment of this disease is exceedingly important. From the current guidelines, physicians are encouraged to administrate mineralocorticoid receptor antagonists (MRA) to the patients with bilateral type of this disease, so-called idiopathic hyperaldosteronism (IHA). However, it is recently demonstrated that the benefit of this medicine is only exerted in the patients with enough PRA elevation after MRA treatment. We retrospectively evaluated the predictors for the patients who exceed plasma renin activity (PRA) > 1.0 ng/ml/h at arbitrary chance after MRA administration from baseline characteristics and the result of confirmatory tests.

Design and method:
Our study protocol was approved by the Ethics Committee of The Jikei University School of Medicine (No. 31-271). 67 patients who received eplerenone for PA are included. We included the patients exceed plasma renin activity (PRA) > 1.0 ng/ml/h at arbitrary chance within a year after MRA administration in Group A, and the patients who did not were included in Group B.

Results:
The eplerenone dose was comparable in two groups (Group A: 47.7 ± 13.1 v.s. Group B: 46.7 ± 14.4 P = 0.78). The patients in Group A were younger, and baseline PRA was lower in Group A. PRA after furosemide upright test, plasma aldosterone concentration (PAC) after saline infusion test, and PAC and PAC/F (Cortisol) after rapid adrenocorticotropic hormone (ACTH) stimulation test were higher in the Group A. Above all, it is revealed with Receiver operating characteristic curve analyses that PAC/F after rapid ACTH stimulation test at the cut-off value of 12.4 was proved to have the highest Area Under Curve (AUC) among all the indices (AUC 0.770).

Conclusions:
In conclusion, rapid ACTH stimulation test might be useful for discriminating the patients sensitive to MRA treatment.
A DIRE WOLF IN WOLF'S CLOTHING
Authors: Farhi Hannane El , Giudiceandrea F. , Jeewooth A. , Koffi M. , Lahjouji J. 
Published: April 2021

Objective:
Takotsubo cardiomyopathy is often attributed to women over 60 years of age as a result of an emotional event stress.
Pheochromocytoma is a rare etiology that can mimic Takotsubo cardiomyopathy through hypersecretion of catecholamines.
This case is that of a patient presenting with atypical Takotsubo cardiomyopathy fortuitously discovered in a context of intense paroxysmal migraine.

Design and method:
A 38 year old female patient with a medical history of migraine, depression, anorexia, and an active smoking attends the emergency for frontal-orbital migraine headache, bilateral otalgia and myodesopsia. arterial blood pressure at 175/95 mmHg,The patient received analgesic treatment and a cerebral CT scan was performed with a normal outcome. Her ECG showS incidental findings of ST depression in V1-V2 and negative T waves in upper lateral leads(DI, AVL). HS troponin levels are elevated. The patient received a triple antithrombotic therapy transferred to our hospital for emergency coronary angiogram. Upon arrival, the patient is asymptomatic, BP 145/75 mmHg, and received emergency coronary angiogram revealing a healthy coronary artery up and the ventriculography detected a ballooning of the left ventricle. TTE findings are an altered LVEF estimated at 40%, apical akinesia and hypokinesia of the adjacent segments, an apical ballooning. The rest of the TEE is normal. Takotsubo is evoked. hospitalization is marked by a normalization of the patient's ECG. 2 days after the coronography, the patient presents with intense recurrence of migraines, ST depression on leads V1-V2 and a severe hypertensive crisis at 220/160mmHg. After initiating an IV antihypertensive treatment, there is a regression of the symptomatology and electrocardiographic changes.

Results:
Atypical Takotsubo associated with HTN crisis resulted in the panel of secondary HTN.
CT scan findings show an adrenal mass. The normetanephrine values and total metanephrine values are elevated. These elements are in favor of a pheochromocytoma.

Conclusions:
The patient presented an atypical picture of ACS. The initial diagnosis associated with paroxysmal hypertensive flare-ups are the result of an underlying pheochromocytoma.
It is important not to settle for a diagnosis of exclusion without mentioning all possible etiologies and thus reduce the morbidity and mortality of this pathology.
SCREENING OF PRIMARY ALDOSTERONISM WITH A NOVEL RENIN-ANGIOTENSIN-ALDOSTERONE SYSTEM TRIPLE-A ANALYSIS
Authors: Burrello Jacopo , Buffolo Fabrizio , Domenig Oliver , Tetti Martina , Pecori Alessio , Monticone Silvia , Poglitsch Marko , Mulatero Paolo 
Published: April 2021

Abstract

Objective:
Primary aldosteronism (PA) is the most frequent cause of endocrine hypertension and its screening is expected to become a routine evaluation in hypertensive patients. The interference of antihypertensive medications with the Aldosterone-to-Renin-Ratio (ARR) is a major confounder during screening testing. Renin-angiotensin-aldosterone system (RAAS) triple-A analysis is a novel liquid chromatography/tandem mass spectrometry diagnostic assay that allows simultaneous quantification of aldosterone, equilibrium angiotensin I (eqAngI) and equilibrium angiotensin II (eqAngII) from a single serum sample. The aim of the present study was to assess the reliability of RAAS triple-A analysis for the screening of PA.

Design and method:
We performed a comparative evaluation of the diagnostic performance of the Aldosterone-to-AngII-Ratio (AA2R) and five renin based diagnostic ratios, differing in methods to determine aldosterone levels and renin activity, either based on chemiluminescence or radioimmunoassay.

Results:
We prospectively enrolled a cohort of 110 patients with hypertension and suspected PA referred to a single hypertension unit (33 patients with confirmed PA and 77 with essential hypertension). All ratios showed comparable areas under the curves ranging between 0.924 and 0.970 without significant differences between each other. The evaluation of the AngII-to-AngI ratio revealed persistent ACE inhibitor intake in some patients as cause for suppressed renin-based diagnostic ratios, while AA2R remained unaffected, allowing a AA2-R-based PA screening in presence of ACE inhibitor and providing major advantage over currently available tests.
The Youden-Index optimal cut-off value for the AA2R was 6.6 [(pmol/L)/(pmol/L)] with a sensitivity of 90% and a specificity of 93%, non-inferior compared with the ARR while pointing to the potential for an interference free application in patients under ACE-inhibitor therapy.

Conclusions:
This study shows for the first time the accuracy and reliability of RAAS triple-A analysis for the screening of PA, even in the presence of theraphy with ACE inhibitors. Combining informations on drug efficacy and compliance monitoring with PA screening, this method might have a significant impact on the overall performance of PA screening procedures.
LEFT VENTRICULAR HYPERTROPHY IN WOMEN AND MEN WITH PRIMARY ALDOSTERONISM
Authors: Aune Arleen , Kokorina Marina , Saeed Sahrai , Grytaas Marianne , Løvås Kristian , Gerdts Eva 
Published: April 2021

Abstract

Objective:
Primary aldosteronism (PA) is the leading cause of secondary hypertension and has been associated with higher prevalence of left ventricular hypertrophy (LVH) compared to essential hypertension (EH). In EH, women have higher prevalence of LVH than men. Whether this also applies to PA patients remains unknown. We aimed to compare the prevalence and type of LVH in women and men with PA.

Design and method:
109 patients (mean age 57 ± 11 years, 32% women) recently diagnosed with PA according to current guidelines, underwent echocardiography and ambulatory blood pressure monitoring. LVH was identified using guideline recommended sex-specific values. Post saline infusion test (SIT) aldosterone level was considered an indicator of PA-severity.

Results:
Women had a shorter duration of hypertension than men (9 ± 9 vs. 16 ± 10 years, p < 0.001), lower BMI (28 ± 6 vs. 31 ± 5 kg/m2, p = 0.04) and lower prevalence of diabetes (6 vs. 23%, p = 0.034), while clinical and ambulatory blood pressure and post-SIT aldosterone level did not differ. LVH was more prevalent in men than women (63% vs. 41%, p = 0.04), eccentric hypertrophy was the most common geometric pattern in both sexes. In univariate logistic regression analyses, male sex, higher BMI, night-time blood pressure and co-presence of diabetes were all associated with prevalent LVH, while post-SIT aldosterone level was not. In multivariate analysis, the association of male sex with prevalent LVH became statistically non-significant when adjusted for confounder (Table 1).

Conclusions:
The higher prevalence of LVH in men than women with PA in our study was fully explained by differences in BMI and nocturnal hypertension, independent of PA-severity.
EFFECT OF ADRENALECTOMY ON REMISSION OF SUBCLINICAL LEFT VENTRICULAR DYSFUNCTION IN PATIENTS WITH PHEOCHROMOCYTOMA: A SPECKLE-TRACKING ECHOCARDIOGRAPHY STUDY
Authors: Kvasnicka Jan , Zelinka Tomas , Petrak Ondrej , Kratka Zuzana , Indra Tomas , Widimsky Jiri 
Published: April 2021

Abstract

Objective:
Pheochromocytomas (PHEO) are tumors arising from chromaffin cells from the adrenal medulla, having the ability to produce, metabolize and secrete catecholamines. The overproduction of catecholamines leads by many mechanisms to the decline of longitudinal function of the left ventricle measured by speckle tracking echocardiography. Patients with PHEO have a lower magnitude of global longitudinal strain (GLS) than the patients with essential hypertension, although the ejection fraction of left ventricle (LV EF) remains in normal range.

Design and method:
We analysed 24 patients (14 females and 10 males) with recent diagnosis of PHEO and one year after adrenalectomy. We performed an echocardiographic examination including the evaluation of GLS by speckle tracking analysis.

Results:
One year after adrenalectomy magnitude of GLS increased (-14.3 ± 1.8 to -17.7 ± 1.6 %; p < 0.001), although values of LV EF remained unchanged (0.66 ± 0.07 vs. 0.65 ± 0.05; n.s.). In addition, there was also found a decrease in the indexed mass of the left ventricle (95.3 ± 18.7 to 83.6 ± 17.8 g/m2; p < 0.05).

Conclusions:
In patients with PHEO, adrenalectomy leads to an improvement of subclinical left ventricular dysfunction represented by increasing magnitude of GLS.
NUMBER AND REPLATING CAPACITY OF ENDOTHELIAL COLONY FORMING CELLS ARE TELOMERE LENGTH DEPENDENT: IMPLICATION FOR HUMAN ATHEROGENESIS
Authors: Toupance Simon , Simoncini Stéphanie , Labat Carlos , Dumoulin Chloé , Lai Tsung-Po , Ayad Oualid , Lakomy Cécile , Aviv Abraham , Dignat-George Françoise , Sabatier Florence , Benetos Athanase 
Published: April 2021

Abstract

Objective:
Short leukocyte telomere length (TL) is associated with atherosclerotic cardiovascular disease. Endothelial repair plays a key role in the development of atherosclerosis. To explore a potential role of short TL in atherogenesis, we examined associations between TL and proliferative dynamics of endothelial colony forming cells (ECFCs), which behave as progenitor cells displaying endothelial repair activity.

Design and method:
To isolate ECFCs, we performed a clonogenic assay on blood samples from 116 participants (24 to 94 years old) in the TELARTA (Telomere in Arterial Aging) study. We detected no ECFC clone in 29 (Group 1), clones with no replating capacity in other 29 (Group 2), and clones with replating capacity in additional 58 (Group 3). TL was measured by Southern blotting in leukocytes (LTL) and ECFCs (ECFC-TL).

Results:
Age- and sex-adjusted LTL (mean ± SEM) was the shortest in Group 1 (6.51 ± 0.13 kb), longer in Group 2 (6.69 ± 0.13 kb) and the longest in Group 3 (6.78 ± 0.09 kb) (p < 0.05). In group 3, ECFC-TL was associated with the number of detected clones (p < 0.01). ECFC-TL (7.98 ± 0.13 kb) was longer than LTL (6.74 ± 0.012 kb) (p < 0.0001) and both parameters were strongly correlated (r = 0.82; p < 0.0001).

Conclusions:
Individuals with longer telomeres display a higher number of self-renewing ECFCs suggesting that they might have a better endothelial repair capacity. Our results also indicate that LTL, as a proxy of TL dynamics in ECFCs, could be used as a surrogate marker of endothelial repair capacity in clinical and laboratory practice due to easy accessibility of leukocytes.