Evaluating the effects of bariatric surgery on heart failure and atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess whether a bariatric surgery strategy can enhance clinical outcomes, cardiac function, and overall health in obese patients suffering from heart failure with preserved ejection fraction and atrial fibrillation. Participants will be randomly assigned to receive either bariatric surgery with a comprehensive pre- and postoperative care plan or standard care. The primary focus is on measuring all-cause mortality, hospital visits for heart failure, recurrence of atrial fibrillation, changes in left ventricular mass, and improvements in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire over a two-year period.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Center Groningen
  Groningen, Provincie Groningen, Netherlands Recruiting
• Rijnstate Hospital
  Arnhem, Gelderland, Netherlands Active not recruiting

Study contacts

• Principal investigator: Michiel Rienstra, MD, PhD — University Medical Center Groningen
• Study coordinator: Michiel Rienstra, MD, PhD
• Email: m.rienstra@umcg.nl
• Phone: +31503611327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.