Design of the Middle East African Registry for Women's Cardiovascular Diseases: Protocol for a Multicenter Observational Study.

BACKGROUND: Cardiovascular disease (CVD) is a leading cause of morbidity and mortality in the Middle East and Africa (MEA), with a rising incidence particularly among women. Regional factors such as limited health care access, cultural barriers, and sex-specific risk factors exacerbate this burden. Despite this, women remain significantly underrepresented in cardiovascular research, and no large-scale, multicenter prospective trials have been conducted to provide national data. To address this gap, we established the Middle East African Registry Women Cardiovascular Disease (MEA-WCVD) to create a comprehensive database on the epidemiological profile and management of heart failure (HF), atrial fibrillation (AF), ischemic heart disease (IHD), and valvular heart disease (VHD) in women.

OBJECTIVE: The primary aim of this study is to compare the management of CVDs in women and men across MEA countries in accordance with current clinical practice guidelines. The study also seeks to identify gender-based disparities in health care insurance, income, and access to cardiovascular services.

METHODS: The MEA-WCVD is a prospective, multicenter, observational study enrolling consecutive patients aged ≥18 years with diagnosed HF, AF, IHD, or VHD across 25 tertiary care centers. Participants provide informed consent during a single visit, and trained investigators collect sociodemographic, clinical, and treatment data via electronic case report forms. The electronic case report form captures general characteristics (age, gender, and comorbidities) and diagnosis-specific details (imaging, guideline-based therapies, and complications). Data are stored in a centralized, contract research organization-managed database (Eshmoun-Clinical Research, Tunisia). An initial 75-day enrollment phase (May 2023-July 2023) is followed by a planned 1-year follow-up for outcome analysis. Data will be analyzed using SPSS (version 25) to compare gender disparities in management and outcomes using multivariable regression and survival analyses.

RESULTS: The MEA-WCVD study was funded in April 2023, and data collection began in May 2023. As of July 2023, a total of 15,366 participants have been enrolled across 25 centers. A 1-year follow-up is expected to be completed by July 2024. Data analysis is planned to commence in July 2024, with primary results anticipated for publication in March 2025. The study aims to establish the largest registry in the MEA region for HF, AF, IHD, and VHD, providing valuable insights into demographic trends, clinical management, and adherence to current guidelines.

CONCLUSIONS: The MEA-WCVD registry will provide essential real-world data on the management and outcomes of the most prevalent CVDs (HF, AF, IHD, and VHD) in the MEA region. By directly comparing standard care management between men and women, this study will highlight gender disparities and inform future strategies for equitable cardiovascular care. The registry is expected to contribute to the largest contemporary cohort of patients with CVD in the region, advancing knowledge in cardiovascular epidemiology and clinical practice.