Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00005868

Trial Description

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Title

Supervised Obesity Reduction Trial for AF Ablation Patients

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Trial Acronym

SORT-AF

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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-lable 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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005868
  •   2014/09/10
  •   2014/02/13
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT02064114  (ClinicalTrials.gov)
  •   PV4300  (Universitätsklinikum Hamburg-Eppendorf)
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Health Condition or Problem studied

  •   Atrial Fibrillation
  •   Obesity
  •   Sleep Apnea
  •   I48 -  Atrial fibrillation and flutter
  •   E66 -  Obesity
  •   G47.3 -  Sleep apnoea
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Interventions/Observational Groups

  •   Procedure: Intervention group
  •   Procedure: control group
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

- Recurrence of sustained atrial fibrillation; time frame: 12 months; Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation

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Secondary Outcome

- Coincidence of sleep apnea; time frame: 12 months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2014/01/31
  •   140
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Age ≥ 18 years

- Overweight with a BMI ≥ 30

- Obtained written informed consent

- Symptomatic atrial fibrillation with indication for ablation

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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

- Incompliants

- Unable to perform athletic exercise due to disease or disability

- Resident outside Hamburg

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf
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    •   [---]*
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    • St. Jude Medical
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    •   [---]*
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    • University Heart Center Hamburg
    • Stephan Willems 
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    •   [---]*
    •   [---]*
    •   [---]*
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    • Jakob Lueker 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.