NCT06065124Recruiting
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
Source: ClinicalTrials.gov · Last updated 1 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- First submitted
- 23 Aug 2023
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT06065124
What you commit to
- Study type: Interventional
- Planned participants: 108
- From 1 Jul 2024 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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;
Age
- Any medical condition that limits life span \<2 years;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 45 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rijnstate Hospital Coordinator of this site? Confirm its status | Arnhem | Netherlands | Active, not recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.