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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Atrial Fibrillation
• Intervention / Treatment: Behavioral: Physician-lead complex program of weight-reducing interventions; Procedure: Bariatric surgery - sleeve gastrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristyna Stolbova, MD; Phone Number: +420 728 375 528; Email: kristyna.stolbova@ikem.cz

Study Locations

• Czechia
  • Prague, Czechia, 14021
    • Recruiting
    • Institute for Clinical and Experimental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation burden	Atrial fibrillation burden expressed as % of total monitoring time at final visit	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of AF episodes on 14-day Holter monitoring	Number of AF episodes on 14-day Holter monitoring	18 months
Progressive reduction of AF burden between 12- and 18-month follow up visit	Progressive reduction of AF burden between 12- and 18-month follow up visit	18 months
hsCRP		18 months
Epicardial adipose tissue volume	Assessed by transthoracic echocardiography	18 months
Concentration of atrial natriuretic peptide (ANP)		18 months
Concentration of brain natriuretic peptide (BNP)		18 months

Collaborators and Investigators

• Sponsor: Martin Haluzik

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 21, 2020
• Primary Completion (ANTICIPATED): October 31, 2024
• Study Completion (ANTICIPATED): June 30, 2025

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (ACTUAL): September 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NU20-02-00190

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No