Impact of weight loss programs on heart rhythm in obese patients with atrial fibrillation
Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
This study is testing if different weight loss programs can help obese patients with atrial fibrillation feel better after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute for Clinical and Experimental Medicine Government |
| Locations | 1 site (Prague) |
| Trial ID | NCT04560387 on ClinicalTrials.gov |
What this trial studies
This study evaluates how different weight-reducing interventions affect the burden of atrial fibrillation (AF) in obese patients who have undergone catheter ablation for AF. Participants will be randomly assigned to either a complex weight loss program, which may include diet, lifestyle counseling, and bariatric surgery, or to standard care without specific obesity interventions. The goal is to achieve a sustained weight loss of more than 10% of initial body weight and to identify which patient profiles benefit most from these interventions. The study aims to explore the mechanisms linking obesity and AF.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI of 30 kg/m2 or higher, who have paroxysmal or persistent atrial fibrillation scheduled for ablation.
Not a fit: Patients with a history of recent myocardial infarction, stroke, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of atrial fibrillation in obese patients through effective weight loss strategies.
How similar studies have performed: Other studies have indicated that weight loss can positively impact atrial fibrillation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Paroxysmal or persistent AF scheduled for primary RF ablation * BMI ≥30 kg/m2 * Age 18-70 years * Informed consent to the study Exclusion Criteria: * Previous ablation for AF * Myocardial infarction, stroke or pulmonary embolism \< 3 months prior to inclusion * left ventricular ejection fraction \< 40% * Left atrium diameter \> 55 mm * Active thyroid disease * Chronic kidney disease stage IV-V (eGFR \< 0.5 ml/s) * Chronic liver disease * Active malignancy * Inability to comply with study procedures
Where this trial is running
Prague
- Institute for Clinical and Experimental Medicine — Prague, Czechia (Recruiting)
Study contacts
- Study coordinator: Kristyna Stolbova, MD
- Email: kristyna.stolbova@ikem.cz
- Phone: +420 728 375 528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.