|Year : 2018 | Volume
| Issue : 3 | Page : 81-84
Design and rationale of gulf documentation of ambulatory sick patients with heart failure (Gulf DYSPNEA) registry
Mohammad Zubaid1, Wafa Rashed2, Mustafa Ridha3, Mohammad Al-Jarallah4, Adel Hamad5, Rashed Al Banna6, Kadhim Sulaiman7, Nooshin Bazargani8, Wael Almahmeed9, Arif Al Mulla10, Fahad Baslaib11, Nidal Asaad12, Sreeja Attur1
1 Department of Medicine, Faculty of Medicine, Kuwait University, Kuwait City, Kuwait
2 Department of Medicine, Mubarak Al-Kabeer Hospital, Kuwait City, Kuwait
3 Department of Cardiology, Al Dabbous Cardiac Centre, Kuwait City, Kuwait
4 Department of Cardiology, Sabah Al-Ahmed Cardiac Center, Kuwait City, Kuwait
5 Mohammed Bin Salman Al Khalifa Cardiac Centre, Bahrain Defence Force Hospital, Manama, Bahrain
6 Department of Cardiology, Salmaniya Medical Complex, Manama, Bahrain
7 Department of Cardiology, Royal Hospital, Muscat, Oman
8 Department of Cardiology, Dubai Hospital, Dubai, United Arab Emirates
9 Department of Medicine, Cleveland Clinic, Abu Dhabi, United Arab Emirates
10 Department of Cardiology, Cardiac Sciences Institute, Sheikh Khalifa Medical City, Abu Dhabi, United Arab Emirates
11 Department of Cardiology, Rashid Hospital, Dubai, United Arab Emirates
12 Department of Cardiology, Hamad Medical Corporation, Doha, Qatar
|Date of Web Publication||18-Mar-2019|
Prof. Mohammad Zubaid
Department of Medicine, Faculty of Medicine, Kuwait University
Source of Support: None, Conflict of Interest: None
| 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”.
Keywords: Arabian gulf, heart failure, registry
|How to cite this article:|
Zubaid M, Rashed W, Ridha M, Al-Jarallah M, Hamad A, Al Banna R, Sulaiman K, Bazargani N, Almahmeed W, Al Mulla A, Baslaib F, Asaad N, Attur S. Design and rationale of gulf documentation of ambulatory sick patients with heart failure (Gulf DYSPNEA) registry. Heart Views 2018;19:81-4
|How to cite this URL:|
Zubaid M, Rashed W, Ridha M, Al-Jarallah M, Hamad A, Al Banna R, Sulaiman K, Bazargani N, Almahmeed W, Al Mulla A, Baslaib F, Asaad N, Attur S. Design and rationale of gulf documentation of ambulatory sick patients with heart failure (Gulf DYSPNEA) registry. Heart Views [serial online] 2018 [cited 2020 May 28];19:81-4. Available from: http://www.heartviews.org/text.asp?2018/19/3/81/254352
| Introduction|| |
Heart failure (HF) is a major global health problem due to its widespread prevalence, increasing the incidence and poor outcomes., Although advances in both pharmacological and device treatment in the past three decades have improved survival and decreased hospital readmissions, HF is still associated with significant mortality, morbidity, and poor quality of life., Adherence to the management guidelines of HF is important for improving outcomes, as the recommended treatments have been shown in multiple clinical trials to be beneficial in decreasing rates of death and hospitalization.
Registries are good research tools in characterizing patients with HF and assessing real-life practice and adherence to management guidelines, and therefore are useful in improving health-care delivery to such patients.,,,
Two recent regional registries provided useful data on acute and severe chronic HF. The Gulf acute HF registry (Gulf CARE) surveyed acute HF admissions in seven Arabian Gulf countries, while the Heart Function Assessment Registry Trial in Saudi Arabia, studied acute and high-risk chronic HF admitted to hospital or visiting HF clinics in Saudi Arabia., However, there is still a paucity of regional data concerning the characteristics and management of ambulatory patients with chronic HF.
Gulf documentation of ambulatory sick patients with HF (Gulf DYSPNEA) registry was designed and carried out to fill this knowledge gap. The goals of Gulf DYSPNEA registry are to provide more information about HF patients visiting hospital clinics in the Arabian Gulf. Several features will be explored including demographics, clinical characteristics, and types of HF in our population and their management. The aim of this report is to detail the design and methodology of this registry.
| Methods|| |
Gulf DYSPNEA is a multicenter, cross-sectional, disease survey of adult ambulatory HF patients visiting hospital outpatient clinics. As the registry is observational, no specific investigational or management recommendations were imposed. Recruitment complied with the Declaration of Helsinki. The individual ethics bodies of each participating country/center approved the study protocol.
Study organization and timeline
Gulf DYSPNEA registry is led by a steering committee chaired by the principal investigator and comprised cardiologists from the five participating countries. Each hospital had a chief site officer, a cardiologist, who invited clinics in the hospital to participate in the study, supervised enrolment and checked data entered for accuracy. In addition, several site officers at each hospital who were nurses, general practitioners, internists, or cardiologists enroled patients and collected data on a case report form (CRF).
Recruitment started on November 07, 2016 and was planned to conclude when a sample size of 4,000 patients is reached. By late December 2017, the steering committee decided to stop enrolment at 3,500 patients due to the slowing of recruitment and desire to publish the results earlier. This was discussed with the registry statisticians who approved the decision (see sample size calculation).
Site selection and participating hospitals
Members of the steering committee were asked to invite hospitals from their respective countries to participate in the registry. Hospitals from different geographical areas and of different types (community hospitals, tertiary hospitals, and university-affiliated hospitals) were included in the study. In each hospital, HF patients were recruited from clinics run by general practitioners, internists, cardiologists, and HF specialists. The aim was to involve a broad spectrum of health-care providers and a variety of outpatient facilities, to ensure that the study sample would be a good representation of the patient population with HF and their management in the Gulf region.
Patients were enrolled from outpatient clinics in 24 hospitals across five Arabian Gulf countries during a scheduled visit (two hospitals from Bahrain, 6 from Kuwait, 1 from Qatar, 9 from Oman and 6 from United Arab Emirates ). Of the 24 participating hospitals, 10 were tertiary hospitals, nine were community hospitals and five were university-affiliated. Nine of the participating hospitals had HF clinics.
Consecutive HF patients presenting to the outpatient clinic were enrolled after signing a written informed consent and fulfilling the following criteria: (1) they had to be over 21-year-old, (2) they had to have been admitted to hospital with a diagnosis of HF >3 months prior to the enrolment, and (3) they had to have a documented echocardiography study.
Data collection and quality
Data collected were entered online (www.gulfdyspnea.com) by the individual investigators. Variables used in the CRF were based on the American College of Cardiology/American Heart Association key data elements and definitions for measuring the clinical management and outcomes of patients with chronic HF. The types of HF according to left ventricular ejection fraction (LVEF) followed the classification in the recent guidelines. Reduced EF was defined as LVEF <40%, midrange EF as LVEF 40%–49% and preserved EF as LVEF ≥50%.
Data collected included demographic data; main underlying cause of HF; current symptoms including New York Heart Association class; past medical history and comorbidities; tobacco and alcohol use; vaccinations in the previous year; physical signs; laboratory investigations; electrocardiogram (ECG), echocardiogram, and 24-h ECG recording findings; the current medications (with dosage); device treatment including implantable cardioverter-defibrillator and cardiac resynchronization therapy, past cardiac surgery including heart transplantation; participation in cardiac rehabilitation program; reported adherence to medications and salt restriction; history of renal impairment with HF medications; and number of HF emergency room visits and hospital admissions in the previous year.
To ensure data accuracy, the online data entry system had built-in automated data checks that were immediately displayed during data entry if an out of range value was entered or a variable had a missing value. In addition, the chief site officer of every hospital reviewed CRFs for accuracy and missing fields, and a registry research assistant carried out periodic data cleaning using IBM® SPSS® Statistics 25 Program (IBM, USA).
Case report form
The CRF is shown in [Figure 1]. It collected data on the main reason for HF, current symptoms, previous medical history and comorbidities, smoking and alcohol use, emergency room visits and hospital admissions for HF in the past year, physical examination, presenting ECG, echocardiographic findings, medications prescribed, previous medication side-effects, self-reported compliance to fluid restriction, diet and medications, cardiac device use, cardiac transplantation, participation in cardiac rehabilitation, and follow-up arrangements. It also collected data on the specialty of the primary treating physician (general practitioner, internist, and cardiologist or HF specialist) and whether the patient is following a specialized HF clinic.
Sample size and statistical analysis
In justifying the sample size for this registry, we factored in statistical as well as practical considerations. We assumed the prevalence of HF in the population to be 2.5% and used most recent World Bank population census of the participating countries. A sample size of 2,398 patients would provide a maximum margin of error of 2% at 95% confidence level for proportions ranging from 1% to 99%. To account for the possibility of about 10% missing data, and to allow for reasonable estimates in key subgroups of the population (e.g., when stratifying the cohort by gender, etiology of HF or LVEF), we set a sample size target of 4,000 patients. Data were entered and were analyzed using SPSS version 25 (SPSS Inc., IBM, USA).
By the end of December 2017, the steering committee noticed slowing recruitment of patients. At the same time, there was a desire to publish the results earlier. It was estimated that the original goal of 4,000 patients could take 8 more months to achieve. The steering committee approached the study statisticians for their opinions. The statisticians' opinion was that reducing the target number of patients to 3,500 would not compromise the registry findings and would keep the safe margin of error preserved. Therefore, it was decided to stop enrolment once recruitment of 3,500 patients with complete data are achieved.
| Discussion|| |
In this manuscript, we describe the methodology of Gulf DYSPNEA. The planned number of patients is statistically sound and meaningful. We expect it to provide us data that shed light on the causes of HF in our communities. In addition, many other areas of HF care will be explored including patient demographics, quality of life, and management. The dissemination of the results, whether positive or negative, will open the door to important discussions and debates about the fate of HF patients in the region.
Study limitations and strengths
Based on a large cohort of ambulatory patients with chronic HF, this study is expected to provide useful data. We do realize the inherent bias of registries as unobserved variables may exert a confounding effect on the results of observational studies. Possible selection bias exists about the specialty of doctors involved in data collection.
Financial support and sponsorship
Gulf DYSPNEA is an investigator-initiated study that was sponsored by Gulf Heart Association and funded by Novartis Pharmaceuticals Corporation (study code CLCZ6969BKW01T). Novartis did not play any role in study design, data collection, data management, or writing of the manuscript.
Conflicts of interest
There are no conflicts of interest.
| References|| |
Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S, et al.
Heart failure: Preventing disease and death worldwide. ESC Heart Fail 2014;1:4-25.
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, et al.
Heart disease and stroke statistics-2016 update: A report from the American Heart Association. Circulation 2016;133:e38-360.
Sacks CA, Jarcho JA, Curfman GD. Paradigm shifts in heart-failure therapy – A timeline. N Engl J Med 2014;371:989-91.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al.
2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J 2016;37:2129-200.
Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, et al.
Improving evidence-based care for heart failure in outpatient cardiology practices: Primary results of the registry to improve the use of evidence-based heart failure therapies in the outpatient setting (IMPROVE HF). Circulation 2010;122:585-96.
Maggioni AP, Anker SD, Dahlström U, Filippatos G, Ponikowski P, Zannad F, et al.
Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC Heart Failure Long-Term Registry. Eur J Heart Fail 2013;15:1173-84.
Hassanein M, Abdelhamid M, Ibrahim B, Elshazly A, Aboleineen MW, Sobhy H, et al.
Clinical characteristics and management of hospitalized and ambulatory patients with heart failure-results from ESC heart failure long-term registry-Egyptian cohort. ESC Heart Fail 2015;2:159-67.
Tavazzi L, Senni M, Metra M, Gorini M, Cacciatore G, Chinaglia A, et al.
Multicenter prospective observational study on acute and chronic heart failure: One-year follow-up results of IN-HF (Italian network on heart failure) outcome registry. Circ Heart Fail 2013;6:473-81.
Sulaiman K, Panduranga P, Al-Zakwani I, Alsheikh-Ali AA, AlHabib KF, Al-Suwaidi J, et al.
Clinical characteristics, management, and outcomes of acute heart failure patients: Observations from the Gulf acute heart failure registry (Gulf CARE). Eur J Heart Fail 2015;17:374-84.
Alhabeeb W, Elasfar A, AlBackr H, AlShaer F, Almasood A, Alfaleh H, et al.
Clinical characteristics, management and outcomes of patients with chronic heart failure: Results from the heart function assessment registry trial in Saudi Arabia (HEARTS-chronic). Int J Cardiol 2017;235:94-9.
Radford MJ, Arnold JM, Bennett SJ, Cinquegrani MP, Cleland JG, Havranek EP, et al.
ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with chronic heart failure: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing committee to develop heart failure clinical data standards): Developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: Endorsed by the Heart Failure Society of America. Circulation 2005;112:1888-916.