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Design and Rationale of Gulf Documentation of Ambulatory Sick Patients with Heart Failure (Gulf DYSPNEA) Registry.

ABSTRACT: Aim:The aim of this study is to describe the clinical characteristics of ambulatory patients with chronic heart failure (HF) in the Arabian Gulf and to examine several aspects including types of HF, causes, and adherence to management guidelines. Methods:Gulf documentation of ambulatory sick patients with HF (Gulf DYSPNEA) registry is a multicenter, cross-sectional study, recruiting adult ambulatory HF patients from 24 hospitals in five Arabian Gulf countries. Consecutive patients are recruited prospectively from participating clinics with no follow-up data collection. Recruitment started on November 07, 2016 and will stop when 3,500 patients are enrolled in this study. Collected data explore demographics, baseline patient characteristics, symptoms, previous medical history, comorbidities, physical signs, presenting electrocardiogram, echocardiographic findings, types of HF, and management. Conclusion:This registry is expected to provide useful data on several important aspects and features of ambulatory patients with chronic HF in Arabian Gulf countries. The trial registration number is "ClinicalTrials.gov number, NCT02793180".

SUBMITTER: Zubaid M

PROVIDER: S-EPMC6448477 | biostudies-literature | 2018 Jul-Sep

REPOSITORIES: biostudies-literature

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Design and Rationale of Gulf Documentation of Ambulatory Sick Patients with Heart Failure (Gulf DYSPNEA) Registry.

Zubaid Mohammad M Rashed Wafa W Ridha Mustafa M Al-Jarallah Mohammad M Hamad Adel A Al Banna Rashed R Sulaiman Kadhim K Bazargani Nooshin N Almahmeed Wael W Al Mulla Arif A Baslaib Fahad F Asaad Nidal N Attur Sreeja S

Heart views : the official journal of the Gulf Heart Association 20180701 3

<h4>Aim</h4>The aim of this study is to describe the clinical characteristics of ambulatory patients with chronic heart failure (HF) in the Arabian Gulf and to examine several aspects including types of HF, causes, and adherence to management guidelines.<h4>Methods</h4>Gulf documentation of ambulatory sick patients with HF (Gulf DYSPNEA) registry is a multicenter, cross-sectional study, recruiting adult ambulatory HF patients from 24 hospitals in five Arabian Gulf countries. Consecutive patients ...[more]

PMID: 31007855

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Project description:BACKGROUND:There is paucity of data on heart failure (HF) in the Gulf Middle East. The present paper describes the rationale, design, methodology and hospital characteristics of the first Gulf acute heart failure registry (Gulf CARE). MATERIALS AND METHODS:Gulf CARE is a prospective, multicenter, multinational registry of patients >18 year of age admitted with diagnosis of acute HF (AHF). The data collected included demographics, clinical characteristics, etiology, precipitating factors, management and outcomes of patients admitted with AHF. In addition, data about hospital readmission rates, procedures and mortality at 3 months and 1-year follow-up were recorded. Hospital characteristics and care provider details were collected. Data were entered in a dedicated website using an electronic case record form. RESULTS:A total of 5005 consecutive patients were enrolled from February 14, 2012 to November 13, 2012. Forty-seven hospitals in 7 Gulf States (Oman, Saudi Arabia, Yemen, Kuwait, United Gulf Emirates, Qatar and Bahrain) participated in the project. The majority of hospitals were community hospitals (46%; 22/47) followed by non-University teaching (32%; 15/47 and University hospitals (17%). Most of the hospitals had intensive or coronary care unit facilities (93%; 44/47) with 59% (28/47) having catheterization laboratory facilities. However, only 29% (14/47) had a dedicated HF clinic facility. Most patients (71%) were cared for by a cardiologist. CONCLUSIONS:Gulf CARE is the first prospective registry of AHF in the Middle East, intending to provide a unique insight into the demographics, etiology, management and outcomes of AHF in the Middle East. HF management in the Middle East is predominantly provided by cardiologists. The data obtained from this registry will help the local clinicians to identify the deficiencies in HF management as well as provide a platform to implement evidence based preventive and treatment strategies to reduce the burden of HF in this region.

Project description:IntroductionPatients with heart failure (HF) are classically categorised by left ventricular ejection fraction (LVEF). Efforts to predict outcomes and response to specific therapy among LVEF-based groups may be suboptimal, in part due to the underlying heterogeneity within clinical HF phenotypes. A multidimensional characterisation of ambulatory patients with and without HF across LVEF groups is needed to better understand and manage patients with HF in a more precise manner.Methods and analysisTo date, the first cohort of 1313 out of total planned 3000 patients with and without HF has been enroled in this single-centre, longitudinal observational cohort study. Baseline and 1-year follow-up blood samples and clinical characteristics, the presence and duration of comorbidities, serial laboratory, echocardiographic data and images and therapy information will be obtained. HF diagnosis, aetiology of disease, symptom onset and clinical outcomes at 1 and 5 years will be adjudicated by a team of clinicians. Clinical outcomes of interest include all-cause mortality, cardiovascular mortality, all-cause hospitalisation, cardiovascular hospitalisation, HF hospitalisation, right-sided HF and acute kidney injury. Results from the Preserved versus Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Patients with Heart Failure (PREFER-HF) trial will examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand HF phenotypes, with the ultimate goal of improving precision medicine and clinical outcomes for patients with HF.Ethics and disseminationInformation gathered in this research will be published in peer-reviewed journals. Written informed consent for PREFER-HF was obtained from all participants. All study procedures were approved by the Mass General Brigham Institutional Review Board in Boston, Massachusetts and performed in accordance with the Declaration of Helsinki (Protocol Number: 2016P000339).Trial registration numberPREFER-HF ClinicalTrials.gov identifier: NCT03480633.

Project description:BackgroundThe frequency of heart failure (HF) in Tunisia is on the rise and has now become a public health concern. This is mainly due to an aging Tunisian population (Tunisia has one of the oldest populations in Africa as well as the highest life expectancy in the continent) and an increase in coronary artery disease and hypertension. However, no extensive data are available on demographic characteristics, prognosis, and quality of care of patients with HF in Tunisia (nor in North Africa).ObjectiveThe aim of this study was to analyze, follow, and evaluate patients with HF in a large nation-wide multicenter trial.MethodsA total of 1700 patients with HF diagnosed by the investigator will be included in the National Tunisian Registry of Heart Failure study (NATURE-HF). Patients must visit the cardiology clinic 1, 3, and 12 months after study inclusion. This follow-up is provided by the investigator. All data are collected via the DACIMA Clinical Suite web interface.ResultsAt the end of the study, we will note the occurrence of cardiovascular death (sudden death, coronary artery disease, refractory HF, stroke), death from any cause (cardiovascular and noncardiovascular), and the occurrence of a rehospitalization episode for an HF relapse during the follow-up period. Based on these data, we will evaluate the demographic characteristics of the study patients, the characteristics of pathological antecedents, and symptomatic and clinical features of HF. In addition, we will report the paraclinical examination findings such as the laboratory standard parameters and brain natriuretic peptides, electrocardiogram or 24-hour Holter monitoring, echocardiography, and coronarography. We will also provide a description of the therapeutic environment and therapeutic changes that occur during the 1-year follow-up of patients, adverse events following medical treatment and intervention during the 3- and 12-month follow-up, the evaluation of left ventricular ejection fraction during the 3- and 12-month follow-up, the overall rate of rehospitalization over the 1-year follow-up for an HF relapse, and the rate of rehospitalization during the first 3 months after inclusion into the study.ConclusionsThe NATURE-HF study will fill a significant gap in the dynamic landscape of HF care and research. It will provide unique and necessary data on the management and outcomes of patients with HF. This study will yield the largest contemporary longitudinal cohort of patients with HF in Tunisia.Trial registrationClinicalTrials.gov NCT03262675; https://clinicaltrials.gov/ct2/show/NCT03262675.International registered report identifier (irrid)DERR1-10.2196/12262.

Dataset Information

Design and Rationale of Gulf Documentation of Ambulatory Sick Patients with Heart Failure (Gulf DYSPNEA) Registry.

Publications

Design and Rationale of Gulf Documentation of Ambulatory Sick Patients with Heart Failure (Gulf DYSPNEA) Registry.

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