Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction
Conditions
Keywords
Atrial Fibrillation, Heart Failure with Preserved Ejection Fraction, Bariatric surgery
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).
Interventions
PROCEDUREBariatric surgery strategy
Bariatric surgery including an intensive pre- and postoperative treatment scheme
Sponsors
Rijnstate Hospital
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre, prospective, randomized controlled, open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| All-cause mortality | 2 years | All-cause mortality |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Weight reduction | 2 years | Measuring weight during clinical trial |
| Medication changes after surgery | 2 years | Medication changes after surgery |
| Change in left atrial volume | 2 years | Change in left atrial volume measured by transthoracic echocardiography |
| 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) |
| 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) |
| Change in diameter of epicardial fat | 2 years | Change in diameter of epicardial fat 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 |
| Concomitant cardiovascular conditions and relevant comorbidities | 2 years | Medical history of patient |
Countries
Netherlands
Contacts
Primary ContactMichiel Rienstra, MD, PhD
Backup ContactThomas M Gorter, MD, PhD
Outcome results
None listed