Actively Recruiting
Study of Bariatric Surgery Effects on Heart Failure with Preserved Ejection Fraction and Atrial Fibrillation in Adults Aged 45 to 70
Led by University Medical Center Groningen · Updated on 2025-04-01
108
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This trial investigates whether a bariatric surgery approach can improve health outcomes in patients with obesity BMI 32-40 kgm2 who have heart failure with preserved or mildly reduced left ventricular ejection fraction LVEF together with atrial fibrillation AF. The study compares this surgical strategy to the standard care currently provided to these patients. The goal is to evaluate effects on mortality, heart failure hospital visits, AF recurrence, heart muscle size, and quality of life over a two-year period. Participants are randomly assigned to one of two groups. The intervention group receives bariatric surgery combined with intensive pre- and postoperative care, while the control group receives standard medical treatment without surgery. The trial starts with a screening phase and follows participants for two years to monitor outcomes and health changes. Throughout the study, participants undergo regular assessments including echocardiography to measure heart muscle mass, monitoring for atrial fibrillation episodes, and completing the Kansas City Cardiomyopathy Questionnaire to evaluate their functional status and quality of life. Researchers track emergency room visits, hospitalizations, and mortality. The trial monitors safety and effectiveness over two years, aiming to provide a comprehensive understanding of the surgerys impact on heart failure and atrial fibrillation in obese patients.
CONDITIONS
Brief Title
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Research Team
M
Michiel Rienstra, MD, PhD
T
Thomas M Gorter, MD, PhD
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