Evaluating the effects of bariatric surgery on heart failure and atrial fibrillation
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
This study is testing if bariatric surgery can improve heart health and quality of life for obese patients who have heart failure and atrial fibrillation compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Trial ID | NCT06065124 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether a bariatric surgery strategy can enhance clinical outcomes, cardiac function, and overall health in obese patients suffering from heart failure with preserved ejection fraction and atrial fibrillation. Participants will be randomly assigned to receive either bariatric surgery with a comprehensive pre- and postoperative care plan or standard care. The primary focus is on measuring all-cause mortality, hospital visits for heart failure, recurrence of atrial fibrillation, changes in left ventricular mass, and improvements in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 70 with a BMI between 32 and 40 kg/m2, experiencing heart failure symptoms and atrial fibrillation.
Not a fit: Patients with a BMI outside the 32-40 kg/m2 range or those with significant cardiac valve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health and quality of life for patients with obesity and heart-related conditions.
How similar studies have performed: While bariatric surgery has been explored in various contexts, this specific approach targeting heart failure and atrial fibrillation in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline; 2. Left ventricular ejection fraction ≥40%; 3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test; 4. Between 45 and 70 years of age; 5. BMI 32-40 kg/m2; 6. Paroxysmal or persistent AF with a rhythm control strategy; 7. Willing to undergo both treatment strategies; 8. Written informed consent. Exclusion Criteria: 1. BMI ≥40 kg/m2; 2. BMI \<32 kg/m2; 3. Patients unwilling or unable to sign informed consent; 4. More than moderate mitral valve regurgitation/aortic valve regurgitation; 5. More than mild mitral valve stenosis/aortic valve stenosis; 6. Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score; 7. History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, \<3 months before inclusion; 8. Scheduled for AF ablation; 9. Complex congenital heart disease; 10. Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders; 11. Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery; 12. Any medical condition that limits life span \<2 years; 13. Diseases requiring long term use of anti-inflammatory treatments; 14. The use of medication associated with substantial effects (\>5 kg) on body weight.
Where this trial is running
Arnhem, Gelderland and 1 other locations
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Active_not_recruiting)
- University Medical Center Groningen — Groningen, Provincie Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Michiel Rienstra, MD, PhD — University Medical Center Groningen
- Study coordinator: Michiel Rienstra, MD, PhD
- Email: m.rienstra@umcg.nl
- Phone: +31503611327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.