Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Rijnstate Hospital | Arnhem | Gelderland | Active Not Recruiting |
| University Medical Center Groningen | Groningen | Provincie Groningen | Recruiting |
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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