Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
NCT ID: NCT04560387
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2020-09-21
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
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.
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
Conservative
Routine treatment of obesity
No interventions assigned to this group
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* BMI ≥30 kg/m2
* Age 18-70 years
* Informed consent to the study
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Martin Haluzik
OTHER_GOV
Responsible Party
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Martin Haluzik
Prof. Martin Haluzik, DSc.
Locations
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Institute for Clinical and Experimental Medicine
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Stolbova K, Novodvorsky P, Jakubikova I, Dvorakova I, Mraz M, Wichterle D, Kautzner J, Haluzik M. Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol. Adv Ther. 2021 Apr;38(4):2007-2016. doi: 10.1007/s12325-021-01667-0. Epub 2021 Mar 12.
Other Identifiers
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NU20-02-00190
Identifier Type: -
Identifier Source: org_study_id