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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Bariatric surgery including an intensive pre- and postoperative treatment scheme
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
ACTIVE_NOT_RECRUITINGUniversity Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
RECRUITINGHierarchical endpoint
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)
Time frame: 2 years
All-cause mortality
All-cause mortality
Time frame: 2 years
Emergency room visit or hospitalization for HF
Emergency room visit or hospitalization for HF
Time frame: 2 years
Rate of recurrent AF
Recurrent AF documented on ECG
Time frame: 2 years
Decrease of left ventricular mass
Decrease of ≥30gr of LV mass measured by transthoracic echocardiography
Time frame: 2 years
Kansas City Cardiomyopathy Questionnaire improvement
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)
Time frame: 2 years
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