Actively Recruiting
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Led by University Medical Center Groningen · Updated on 2025-04-01
108
Participants Needed
2
Research Sites
169 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
R
Rijnstate Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signs and symptoms of heart failure according to European Society of Cardiology guidelines
- Left ventricular ejection fraction 40% or higher
- HFA-PEFF score 5 or higher, or score 2-4 with a positive stress test
- Age between 45 and 70 years
- Body mass index (BMI) between 32 and 40 kg/m2
- Paroxysmal or persistent atrial fibrillation managed with a rhythm control strategy
- Willing to undergo either treatment strategy
- Able to provide written informed consent
You will not qualify if you...
- BMI 40 kg/m2 or higher
- BMI less than 32 kg/m2
- Unable or unwilling to provide informed consent
- More than moderate mitral or aortic valve regurgitation
- More than mild mitral or aortic valve stenosis
- Inadequate echocardiographic imaging for left ventricular mass or HFA-PEFF score assessment
- History of myocardial infarction, myocarditis, invasive cardiac intervention, or stroke within 3 months before enrollment
- Scheduled for atrial fibrillation ablation
- Complex congenital heart disease
- Unstable psychotic disorders, severe depression, or personality disorders as advised by psychiatrist
- Unable to care for self or adapt to lifestyle changes after bariatric surgery
- Medical condition limiting life expectancy to less than 2 years
- Diseases requiring long-term anti-inflammatory treatment
- Use of medications causing significant weight change (over 5 kg)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815AD
Active, Not Recruiting
2
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
M
Michiel Rienstra, MD, PhD
CONTACT
T
Thomas M Gorter, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here