NCT02064114

SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients

Supervised Obesity Reduction Trial for AF Ablation Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Obesity
• Sleep Apnea

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	control group	Followed for a period of 3,6 and 12 months after the procedure.

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2014-02-17
• Last updated: 2022-09-19

Locations

4 sites across 1 country: Germany