NCT06065124

Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).

Conditions

• Heart Failure with Preserved Ejection Fraction
• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Bariatric surgery strategy	Bariatric surgery including an intensive pre- and postoperative treatment scheme

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-10-03
• Last updated: 2025-04-01

Locations

2 sites across 1 country: Netherlands