NCT06065124 Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
| NCT ID | NCT06065124 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Heart Failure with Preserved Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2024-07-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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.
Eligibility 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.
Contact & Investigator
Michiel Rienstra, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06065124 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 70 Years, studying Heart Failure with Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06065124 currently recruiting?
Yes, NCT06065124 is actively recruiting participants. Contact the research team at m.rienstra@umcg.nl for enrollment information.
Where is the NCT06065124 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Groningen, Netherlands.
Who is sponsoring the NCT06065124 clinical trial?
NCT06065124 is sponsored by University Medical Center Groningen. The principal investigator is Michiel Rienstra, MD, PhD at University Medical Center Groningen. The trial plans to enroll 108 participants.
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