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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 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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Universitäres Herzzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany
Herzzentrum der Universität zu Köln
Cologne, Germany
Asklepios ST. Georg
Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Start Date
January 1, 2014
Primary Completion Date
January 16, 2020
Completion Date
January 16, 2020
Last Updated
September 19, 2022
142
ACTUAL participants
Intervention group
PROCEDURE
control group
PROCEDURE
Lead Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
NCT06430957
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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