Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
- Conditions
- Atrial FibrillationObesity
- Interventions
- Behavioral: Physician-lead complex program of weight-reducing interventionsProcedure: Bariatric surgery - sleeve gastrectomy
- Registration Number
- NCT04560387
- Lead Sponsor
- Martin Haluzik
- Brief Summary
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of \>10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Paroxysmal or persistent AF scheduled for primary RF ablation
- BMI ≥30 kg/m2
- Age 18-70 years
- Informed consent to the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Bariatric surgery - sleeve gastrectomy Physician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight. Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI \> 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI \> 35 kg/m2 and a presence of metabolic or other complications). Interventional Physician-lead complex program of weight-reducing interventions Physician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight. Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI \> 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI \> 35 kg/m2 and a presence of metabolic or other complications).
- Primary Outcome Measures
Name Time Method Atrial fibrillation burden 18 months Atrial fibrillation burden expressed as % of total monitoring time at final visit
- Secondary Outcome Measures
Name Time Method hsCRP 18 months Epicardial adipose tissue volume 18 months Assessed by transthoracic echocardiography
Number of AF episodes on 14-day Holter monitoring 18 months Number of AF episodes on 14-day Holter monitoring
Concentration of atrial natriuretic peptide (ANP) 18 months Concentration of brain natriuretic peptide (BNP) 18 months Progressive reduction of AF burden between 12- and 18-month follow up visit 18 months Progressive reduction of AF burden between 12- and 18-month follow up visit
Trial Locations
- Locations (1)
Institute for Clinical and Experimental Medicine
🇨🇿Prague, Czechia