Bariatric surgery to evaluate heart failure and atrial fibrillation in people with obesity
Tests bariatric surgery against standard care in adults with obesity, heart failure and atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Key facts
- Where
- Arnhem and Groningen, NetherlandsSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 70 years old?
Source: NCT06065124, who can take part
Where in Netherlands
- Rijnstate HospitalArnhem, NetherlandsNo longer taking part
- University Medical Center GroningenGroningen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT06065124
- Record updated
- 1 April 2025
- Original description
The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.Read full original descriptionShow less
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.
Inclusion: 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: History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion; Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery; The use of medication associated with substantial effects (>5 kg) on body weight; Complex congenital heart disease; Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders; Diseases requiring long term use of anti-inflammatory treatments; Any medical condition that limits life span <2 years; 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; Scheduled for AF ablation.