Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial (BEAT-IT)
Heart Failure With Preserved Ejection Fraction, Atrial Fibrillation
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery
Eligibility Criteria
Inclusion Criteria: Signs and symptoms of HF according to the Europeans Society of Cardiology guideline; Left ventricular ejection fraction ≥40%; HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test; Between 45 and 70 years of age; BMI 32-40 kg/m2; Paroxysmal or persistent AF with a rhythm control strategy; Willing to undergo both treatment strategies; Written informed consent. Exclusion Criteria: BMI ≥40 kg/m2; BMI <32 kg/m2; Patients unwilling or unable to sign informed consent; More than moderate mitral valve regurgitation/aortic valve regurgitation; More than mild mitral valve stenosis/aortic valve stenosis; Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score; History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion; Scheduled for AF ablation; Complex congenital heart disease; Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders; Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery; Any medical condition that limits life span <2 years; Diseases requiring long term use of anti-inflammatory treatments; The use of medication associated with substantial effects (>5 kg) on body weight.
Sites / Locations
- Rijnstate Hospital
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Bariatric surgery strategy
Standard of Care
The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme
The control group will receive standard of care