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

Supervised Obesity Reduction Trial for AF Ablation Patients

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Atrial Fibrillation; Sleep Apnea
• Intervention / Treatment: Procedure: Intervention group; Procedure: control group

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • Herzzentrum der Universität zu Köln
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 20246
    • Asklepios St. Georg
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23562
      • Universitäres Herzzentrum Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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: 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.
Active Comparator: control group; conventional treatment, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Body Mass Index (BMI) change from BL to 12 months	12 months
Exercise capacity change from BL to 12 months	12 months
Mean blood pressure change from BL to 12 months	12 months
Number of repeated AF ablation procedures	12 months
Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months	12 months

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Abbott Medical Devices; Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Principal Investigator: Christian Meyer, University Heart Center Hamburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): January 16, 2020
• Study Completion (Actual): January 16, 2020

Study Registration Dates

• First Submitted: February 13, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: BMI >40
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Arrhythmias, Cardiac; Obesity; Atrial Fibrillation
• Other Study ID Numbers: PV4300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO