Ireland
--:--IST
Recruiting Not applicable

Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

NCT06065124 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2024-07-01
Last updated
2025-04-01

Condition(s) studied

Heart Failure with Preserved Ejection FractionAtrial Fibrillation

Investigational drug(s) / intervention(s)

Bariatric surgery strategy

Bariatric surgery strategy: Bariatric surgery including an intensive pre- and postoperative treatment scheme

Study 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

Sex
ALL
Min age
45 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Hierarchical endpoint — 2 years
    The hierarchical occurrence of: 1) All-cause mortality; 2) Emergency room visit or hospitalization for HF; 3) Recurrent ECG-documented AF; 4) Decrease of ≥30gr of LV mass on transthoracic echocardiography; 5) Improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (Scores are transformed to a range of 0-100, in which higher scores reflect better health status)

Trial sites (2)

FacilityCityRegionStatus
Rijnstate Hospital Arnhem Gelderland Active Not Recruiting
University Medical Center Groningen Groningen Provincie Groningen Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06065124 on ClinicalTrials.gov ↗ ← All trials in the Netherlands