BEAT-IT: Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06065124

Collaborator

Rijnstate Hospital (Other)

108

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction Atrial Fibrillation	Procedure: Bariatric surgery strategy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Multicentre, prospective, randomized controlled, open-label clinical trialMulticentre, prospective, randomized controlled, open-label clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2027

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bariatric surgery strategy The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme	Procedure: Bariatric surgery strategy Bariatric surgery including an intensive pre- and postoperative treatment scheme
No Intervention: Standard of Care The control group will receive standard of care

Arm

Intervention/Treatment

Active Comparator: Bariatric surgery strategy

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

Procedure: Bariatric surgery strategy

Bariatric surgery including an intensive pre- and postoperative treatment scheme

No Intervention: Standard of Care

The control group will receive standard of care

Outcome Measures

Primary Outcome Measures

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

All-cause mortality [2 years]
All-cause mortality
Emergency room visit or hospitalization for HF [2 years]
Emergency room visit or hospitalization for HF
Rate of recurrent AF [2 years]
Recurrent AF documented on ECG
Decrease of left ventricular mass [2 years]
Decrease of ≥30gr of LV mass measured by transthoracic echocardiography
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)

Other Outcome Measures

Weight reduction [2 years]
Measuring weight during clinical trial
Medication changes after surgery [2 years]
Medication changes after surgery
Concomitant cardiovascular conditions and relevant comorbidities [2 years]
Medical history of patient
Change in left atrial volume [2 years]
Change in left atrial volume measured by transthoracic echocardiography
Change in left ventricular diastolic dysfunction [2 years]
Change in left ventricular diastolic dysfunction measured by transthoracic echocardiography with the definition according to the leading guidelines
Change in left ventricular ejection fraction [2 years]
Change in left ventricular ejection fraction measured by transthoracic echocardiography
Change in right ventricular function [2 years]
Change in right ventricular function measured by transthoracic echocardiography with the definition according to the leading guidelines
Change in diameter of epicardial fat [2 years]
Change in diameter of epicardial fat measured by transthoracic echocardiography
Healthcare resource use/costs [2 years]
Measured with the iMedical Consumption Questionnaire (instrument for measuring medical consumption, costs will be estimated by given answers and relation to known costs of the items of medical consumption)
Health related quality of life / utility [2 years]
Measured with the 5-level EQ-5D questionnaire (The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression)

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;
Left ventricular ejection fraction ≥40%;
HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;
Between 45 and 70 years of age;
BMI 32-40 kg/m2;
Paroxysmal or persistent AF with a rhythm control strategy;
Willing to undergo both treatment strategies;
Written informed consent.

Exclusion Criteria:

BMI ≥40 kg/m2;
BMI <32 kg/m2;
Patients unwilling or unable to sign informed consent;
More than moderate mitral valve regurgitation/aortic valve regurgitation;
More than mild mitral valve stenosis/aortic valve stenosis;
Inadequate echocardiographic window for the assessment of LV mass index and/or the echocardiographic criteria needed for the HFA-PEFF score;
History of myocardial infarction, myocarditis, any invasive cardiac intervention (e.g. surgery, percutaneous coronary intervention, ablation) or stroke, <3 months before inclusion;
Scheduled for AF ablation;
Complex congenital heart disease;
Negative treatment advise from a specialized psychiatrist due to non-stabilized psychotic disorders, severe depression and/or personality disorders;
Patients unable to care for themselves or who are unable adapt to inherent lifestyle changes following bariatric surgery;
Any medical condition that limits life span <2 years;
Diseases requiring long term use of anti-inflammatory treatments;
The use of medication associated with substantial effects (>5 kg) on body weight.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem	Gelderland	Netherlands	6815AD
2	University Medical Center Groningen	Groningen		Netherlands	9713GZ

Sponsors and Collaborators

University Medical Center Groningen
Rijnstate Hospital

Investigators

Principal Investigator: Michiel Rienstra, MD, PhD, University Medical Center Groningen
Principal Investigator: Dirk Jan van Veldhuisen, MD, PhD, University Medical Center Groningen
Principal Investigator: Thomas M Gorter, MD, PhD, University Medical Center Groningen