Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

Not Applicable

Recruiting

• Conditions: Heart Failure with Preserved Ejection Fraction; Atrial Fibrillation
• Interventions: Procedure: Bariatric surgery strategy

• Registration Number: NCT06065124
• Lead Sponsor: University Medical Center Groningen

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.

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).

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-10-03
• Study Start: 2024-07-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bariatric surgery strategy	Bariatric surgery strategy	The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Rate of recurrent AF	2 years	Recurrent AF documented on ECG
Kansas City Cardiomyopathy Questionnaire improvement	2 years	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)
Emergency room visit or hospitalization for HF	2 years	Emergency room visit or hospitalization for HF
All-cause mortality	2 years	All-cause mortality
Decrease of left ventricular mass	2 years	Decrease of ≥30gr of LV mass measured by transthoracic echocardiography

Trial Locations

Locations (2)

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands