SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients

Obesity Clinical Trial

— SORT-AF  

Official title:

Supervised Obesity Reduction Trial for AF Ablation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064114
• Other study ID #: PV4300
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 16, 2020

Study information

• Verified date: September 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: January 16, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Obesity
• Sleep Apnea

Intervention

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.
• control group
Followed for a period of 3,6 and 12 months after the procedure.

Locations

Country	Name	City	State
Germany	Herzzentrum der Universität zu Köln	Cologne
Germany	Asklepios ST. Georg	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitäres Herzzentrum Lübeck	Lübeck	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Abbott Medical Devices, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation	AF burden is defined as overall percentage of AF during the observed period.	12 months
Secondary	AF burden between 0 and 12 months after first AF ablation		12 months
Secondary	AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation		12 months
Secondary	Freedom of AF (after 3 months blanking period)		12 months
Secondary	Time to first recurrent AF (after 3 months blanking period)		12 months
Secondary	Body Mass Index (BMI) change from BL to 12 months		12 months
Secondary	Exercise capacity change from BL to 12 months		12 months
Secondary	Mean blood pressure change from BL to 12 months		12 months
Secondary	Number of repeated AF ablation procedures		12 months
Secondary	Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months		12 months