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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52120

Enrollment

108

Registered

2022-06-03

Start date

2024-07-17

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas, boezemfibrilleren atrial fibrillation Heart failure

Interventions

An Intervention group receiving bariatric surgery will be compared to a Control group receiving standard of care. Both groups will be randomized in a 1:1 fashion.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: 1. BMI >=40 kg/m2. 2. BMI 5 kg) on body weight.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
1. To study the effect of bariatric surgery on all individual items of the hierarchical endpoint. 2. To study the effect of bariatric surgery on echocardiographic parameters (eg. LVEF, LV diastolic function, left atrial size, right ventricular function, amount of epicardial fat) at 2 years.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026