Bariatric surgery Evaluation and Assessment of Treatment efficacy in heart failure and preserved ejection fraction - Intervention Trial

Recruiting

• Conditions: obesitas, boezemfibrilleren; atrial fibrillation; Heart failure; 10082206; 10017998

• Registration Number: NL-OMON52120
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 108

Inclusion Criteria

1. Signs and symptoms of HF according to the European Society of Cardiology
guidelines.
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
life-style 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The hierarchical occurrence of: 1) all-cause mortality within 2 year, 2)<br /><br>emergency room visit or hospitalization for HF within 2 year, 3) recurrent<br /><br>ECG-documented AF, 4) >=30gr decrease in left ventricular (LV) mass at 2 year,<br /><br>and 5) improvement of >=5 points on the Kansas City Cardiomyopathy Questionnaire<br /><br>(KCCQ) at 2 year.<br /><br><br /><br>Most endpoints refer to objective endpoints (i.e. mortality, decrease of >=30gr<br /><br>of LV mass and improvement of >=5 points on the KCCQ). An independent endpoint<br /><br>committee consisting of a heart failure cardiologist and an electrophysiologist<br /><br>blinded for baseline characteristics and patient* allocation will assess the<br /><br>other primary endpoints and will allocate whether the endpoint is adequately<br /><br>scored as being hospitalization/ER visit for heart failure and recurrent atrial<br /><br>fibrillation. In case of discrepancy, a third independent cardiologist will be<br /><br>asked.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To study the effect of bariatric surgery on all individual items of the<br /><br>hierarchical endpoint.<br /><br>2. To study the effect of bariatric surgery on echocardiographic parameters<br /><br>(eg. LVEF, LV diastolic function, left atrial size, right ventricular function,<br /><br>amount of epicardial fat) at 2 years.</p><br>