SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Sleep Apnea; Obesity
• Interventions: Procedure: Intervention group; Procedure: control group

• Registration Number: NCT02064114
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Primary Completion: 2020-01-16
• Study Completion: 2020-01-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention 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.
control group	control group	conventional treatment, followed for a period of 3,6 and 12 months after the procedure.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Freedom of AF (after 3 months blanking period)	12 months
Time to first recurrent AF (after 3 months blanking period)	12 months
Number of repeated AF ablation procedures	12 months
Mean blood pressure 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
Body Mass Index (BMI) change from BL to 12 months	12 months
Exercise capacity change from BL to 12 months	12 months

Trial Locations

Locations (4)

Herzzentrum der Universität zu Köln; 🇩🇪 Cologne, Germany

Asklepios ST. Georg; 🇩🇪 Hamburg, Germany

Universitäres Herzzentrum Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany