Clinical trial NCT02064114: SORT - AF Supervised Obesity Reduction Trial for AF Ablation Patients
Official title: Supervised Obesity Reduction Trial for AF Ablation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Obesity
Sleep Apnea
Keywords: BMI >40
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2014-02-17
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation
timeFrame: 12 months
Secondary outcomes:
measure: AF burden between 0 and 12 months after first AF ablation
timeFrame: 12 months
measure: AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation
timeFrame: 12 months
measure: Freedom of AF (after 3 months blanking period)
timeFrame: 12 months
measure: Time to first recurrent AF (after 3 months blanking period)
timeFrame: 12 months
measure: Body Mass Index (BMI) change from BL to 12 months
timeFrame: 12 months
measure: Exercise capacity change from BL to 12 months
timeFrame: 12 months
measure: Mean blood pressure change from BL to 12 months
timeFrame: 12 months
measure: Number of repeated AF ablation procedures
timeFrame: 12 months
measure: Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Universitäres Herzzentrum Lübeck
state: Schleswig-Holstein
city: Cologne
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Hamburg
country: Germany
facility: Asklepios ST. Georg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: University Heart Center Hamburg
name: Christian Meyer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gessler N, Willems S, Steven D, Aberle J, Akbulak RO, Gosau N, Hoffmann BA, Meyer C, Sultan A, Tilz R, Vogler J, Wohlmuth P, Scholz S, Gunawardene MA, Eickholt C, Luker J. Supervised Obesity Reduction Trial for AF ablation patients: results from the SORT-AF trial. Europace. 2021 Oct 9;23(10):1548-1558. doi: 10.1093/europace/euab122.