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

Obesity Clinical Trial

— HOBIT-FS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560387
• Other study ID #: NU20-02-00190
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2020
• Source: Institute for Clinical and Experimental Medicine
• Contact: Kristyna Stolbova, MD
• Phone: +420 728 375 528
• Email: kristyna.stolbova[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: June 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Obesity

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Martin Haluzik

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation burden	Atrial fibrillation burden expressed as % of total monitoring time at final visit	18 months
Secondary	Number of AF episodes on 14-day Holter monitoring	Number of AF episodes on 14-day Holter monitoring	18 months
Secondary	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
Secondary	hsCRP		18 months
Secondary	Epicardial adipose tissue volume	Assessed by transthoracic echocardiography	18 months
Secondary	Concentration of atrial natriuretic peptide (ANP)		18 months
Secondary	Concentration of brain natriuretic peptide (BNP)		18 months