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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064114
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
Abbott Medical Devices
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Obesity Sleep Apnea Procedure: Intervention group Procedure: control group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supervised Obesity Reduction Trial for AF Ablation Patients
Actual Study Start Date : January 2014
Actual Primary Completion Date : January 16, 2020
Actual Study Completion Date : January 16, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. The primary endpoint of the study is defined as AF burden between 3 to 12 months after first AF ablation [ Time Frame: 12 months ]
    AF burden is defined as overall percentage of AF during the observed period.


Secondary Outcome Measures :
  1. AF burden between 0 and 12 months after first AF ablation [ Time Frame: 12 months ]
  2. AF burden between 0 and 3, 3 to 6 and 6 to 12 months after first AF ablation [ Time Frame: 12 months ]
  3. Freedom of AF (after 3 months blanking period) [ Time Frame: 12 months ]
  4. Time to first recurrent AF (after 3 months blanking period) [ Time Frame: 12 months ]
  5. Body Mass Index (BMI) change from BL to 12 months [ Time Frame: 12 months ]
  6. Exercise capacity change from BL to 12 months [ Time Frame: 12 months ]
  7. Mean blood pressure change from BL to 12 months [ Time Frame: 12 months ]
  8. Number of repeated AF ablation procedures [ Time Frame: 12 months ]
  9. Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months Antiarrhythmic drug therapy at 12 months [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064114


Locations
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Germany
Universitäres Herzzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany, 23562
Herzzentrum der Universität zu Köln
Cologne, Germany
Asklepios ST. Georg
Hamburg, Germany, 20246
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Abbott Medical Devices
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators
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Principal Investigator: Christian Meyer University Heart Center Hamburg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02064114    
Other Study ID Numbers: PV4300
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
BMI >40
Additional relevant MeSH terms:
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Atrial Fibrillation
Obesity
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes