Status:
RECRUITING
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Rijnstate Hospital
Conditions:
Heart Failure with Preserved Ejection Fraction
Atrial Fibrillation
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
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)...
Detailed Description
The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06065124
Start Date
July 1 2024
End Date
October 1 2027
Last Update
April 1 2025
Active Locations (2)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815AD
2
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ