SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients (SORT-AF)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Atrial Fibrillation; Obesity; Sleep Apnea

Treatments: Procedure: control group; Procedure: Intervention group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02064114

PV4300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Procedure: Intervention group

control group

Active Comparator group

Description:

conventional treatment, followed for a period of 3,6 and 12 months after the procedure.

Treatment:

Procedure: control group