Atrial Fibrillation, Obesity, Sleep Apnea
Conditions
Keywords
BMI >40
Brief summary
Study hypothesis: Weight reduction in obese patients with atrial fibrillation. Obese patients benefit from an obesity treatment after atrial fibrillation ablation. Study design: A prospective randomized, open-label clinical trial.
Detailed description
Study protocol: The purpose of this study is to proof a professional care of overweight patients with symptomatic atrial fibrillation, as well as the treatment of the risk factors for atrial fibrillation, especially obstructive sleep apnea and hypertension. There is a 1:1 randomization. In the intervention group, patients are followed up in a 6-month intensive care after atrial fibrillation ablation. During the follow up time patients will visit the nutritional advice every two weeks for 6 months. The Follow-up in the control group is standard of care. At baseline, a screening test for obstructive sleep apnea and arterial hypertension will be performed as standard care. The documentation of atrial fibrillation after ablation is made possible by the implantation of an event recorder before atrial fibrillation ablation. Follow up: A follow-up will be performed after 3,6 and 12 months in both groups. Patients in the intervention group will be followed-up every 2 weeks in the first 6 months.
Interventions
PROCEDUREIntervention group
Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.
PROCEDUREcontrol group
Followed for a period of 3,6 and 12 months after the procedure.
Sponsors
Abbott Medical Devices
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Overweight with a BMI ≥ 30 * Obtained written informed consent * Symptomatic atrial fibrillation with indication for ablation
Exclusion criteria
* Age \<18 years * Permanent atrial fibrillation (failed Cardioversion or episode duration \> 12 months) * Previous surgical or interventional therapy of atrial fibrillation * BMI \> 40 * Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment * History of hemorrhagic diathesis or other coagulopathies * Contraindications for oral anticoagulation * Hyper- or hypothyroidism * Drug or chronic alcohol abuse * Has any condition that would make participation not be in the best interest of the subject * Incompliance * Unable to perform athletic exercise due to disease or disability * Resident outside Hamburg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation | 12 months | AF burden is defined as overall percentage of AF during the observed period. |
Secondary
| Measure | Time frame |
|---|---|
| Mean blood pressure change from BL to 12 months | 12 months |
| Number of repeated AF ablation procedures | 12 months |
| AF burden between 0 and 12 months after first AF ablation | 12 months |
| AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation | 12 months |
| Exercise capacity change from BL to 12 months | 12 months |
| Time to first recurrent AF (after 3 months blanking period) | 12 months |
| Body Mass Index (BMI) change from BL to 12 months | 12 months |
| Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months | 12 months |
| Freedom of AF (after 3 months blanking period) | 12 months |
Countries
Germany
Outcome results
None listed