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Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation (HOBIT-FS)

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ClinicalTrials.gov Identifier: NCT04560387
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Martin Haluzik, Institute for Clinical and Experimental Medicine

Brief Summary:
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of >10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Obesity Behavioral: Physician-lead complex program of weight-reducing interventions Procedure: Bariatric surgery - sleeve gastrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional

Physician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight.

Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI > 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI > 35 kg/m2 and a presence of metabolic or other complications).

Behavioral: Physician-lead complex program of weight-reducing interventions
A structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss.

Procedure: Bariatric surgery - sleeve gastrectomy
Bariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation

No Intervention: Conservative
Routine treatment of obesity



Primary Outcome Measures :
  1. Atrial fibrillation burden [ Time Frame: 18 months ]
    Atrial fibrillation burden expressed as % of total monitoring time at final visit


Secondary Outcome Measures :
  1. Number of AF episodes on 14-day Holter monitoring [ Time Frame: 18 months ]
    Number of AF episodes on 14-day Holter monitoring

  2. Progressive reduction of AF burden between 12- and 18-month follow up visit [ Time Frame: 18 months ]
    Progressive reduction of AF burden between 12- and 18-month follow up visit

  3. hsCRP [ Time Frame: 18 months ]
  4. Epicardial adipose tissue volume [ Time Frame: 18 months ]
    Assessed by transthoracic echocardiography

  5. Concentration of atrial natriuretic peptide (ANP) [ Time Frame: 18 months ]
  6. Concentration of brain natriuretic peptide (BNP) [ Time Frame: 18 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paroxysmal or persistent AF scheduled for primary RF ablation
  • BMI ≥30 kg/m2
  • Age 18-70 years
  • Informed consent to the study

Exclusion Criteria:

  • Previous ablation for AF
  • Myocardial infarction, stroke or pulmonary embolism < 3 months prior to inclusion
  • left ventricular ejection fraction < 40%
  • Left atrium diameter > 55 mm
  • Active thyroid disease
  • Chronic kidney disease stage IV-V (eGFR < 0.5 ml/s)
  • Chronic liver disease
  • Active malignancy
  • Inability to comply with study procedures

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): NCT04560387


Contacts
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Contact: Kristyna Stolbova, MD +420 728 375 528 kristyna.stolbova@ikem.cz

Locations
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Czechia
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czechia, 14021
Contact: Martin Haluzik, Prof. DSc.    +420261361111    martin.haluzik@ikem.cz   
Sponsors and Collaborators
Martin Haluzik
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martin Haluzik, Prof. Martin Haluzik, DSc., Institute for Clinical and Experimental Medicine
ClinicalTrials.gov Identifier: NCT04560387    
Other Study ID Numbers: NU20-02-00190
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes