Clinical trial NCT06065124: Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
Official title: Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure with Preserved Ejection Fraction
Atrial Fibrillation
Keywords: Atrial Fibrillation
Heart Failure with Preserved Ejection Fraction
Bariatric surgery
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Rijnstate Hospital
First posted: 2023-10-03
Enrollment: 108
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre, prospective, randomized controlled, open-label clinical trial
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Hierarchical endpoint
timeFrame: 2 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 2 years
measure: Emergency room visit or hospitalization for HF
timeFrame: 2 years
measure: Rate of recurrent AF
timeFrame: 2 years
measure: Decrease of left ventricular mass
timeFrame: 2 years
measure: Kansas City Cardiomyopathy Questionnaire improvement
timeFrame: 2 years
Other outcomes:
measure: Weight reduction
timeFrame: 2 years
measure: Medication changes after surgery
timeFrame: 2 years
measure: Concomitant cardiovascular conditions and relevant comorbidities
timeFrame: 2 years
measure: Change in left atrial volume
timeFrame: 2 years
measure: Change in left ventricular diastolic dysfunction
timeFrame: 2 years
measure: Change in left ventricular ejection fraction
timeFrame: 2 years
measure: Change in right ventricular function
timeFrame: 2 years
measure: Change in diameter of epicardial fat
timeFrame: 2 years
measure: Healthcare resource use/costs
timeFrame: 2 years
measure: Health related quality of life / utility
timeFrame: 2 years
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Michiel Rienstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Dirk Jan van Veldhuisen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Thomas M Gorter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: