Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

NCT ID: NCT06065124

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-10-31

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).

Conditions

Heart Failure with Preserved Ejection Fraction; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bariatric surgery strategy

The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme

Group Type: ACTIVE_COMPARATOR

Bariatric surgery strategy

Intervention Type: PROCEDURE

Bariatric surgery including an intensive pre- and postoperative treatment scheme

Standard of Care

The control group will receive standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bariatric surgery strategy

Bariatric surgery including an intensive pre- and postoperative treatment scheme

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Hospital

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michiel Rienstra, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Dirk Jan van Veldhuisen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Thomas M Gorter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Site Status: ACTIVE_NOT_RECRUITING

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Michiel Rienstra, MD, PhD

Role: CONTACT

m.rienstra@umcg.nl

+31503611327

Thomas M Gorter, MD, PhD

Role: CONTACT

tm.gorter@umcg.nl

Other Identifiers

BEAT-IT trial

Identifier Type: -

Identifier Source: org_study_id