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. 2021 Apr;38(4):2007-2016.
doi: 10.1007/s12325-021-01667-0. Epub 2021 Mar 12.

Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol

Kristýna Štolbová  1   2 , Peter Novodvorský  3   4 , Iva Jakubíková  3 , Iveta Dvořáková  5 , Miloš Mráz  3   6 , Dan Wichterle  1   6 , Josef Kautzner  1 , Martin Haluzík  7   8
Affiliations

Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol

Kristýna Štolbová et al. Adv Ther. 2021 Apr.

Abstract

Introduction: Obesity and atrial fibrillation (AF) pose a significant burden on healthcare systems worldwide. Reduction of body weight has been documented to reduce the risk of AF. Little is known about the effect of different weight-reducing interventions including bariatric surgery in obese individuals on the risk of arrhythmia recurrence following catheter ablation (CA) for AF, and about the pathophysiological mechanisms linking these two conditions.

Methods: The Effect of complex weigHt-reducing interventiOns on rhythm control in oBese subjects wITh Atrial Fibrillation (HOBIT-AF) is a single-blinded, parallel-group randomised controlled trial with 18-month follow-up to assess the effect of complex weight-reducing interventions supported by the use of smart technologies and bariatric surgery on the arrhythmia burden in obese individuals following CA for AF. One hundred and sixty individuals (age 18-70 years, body mass index ≥ 30 kg/m2) will be randomised in a 1:1 fashion to undergo a structured weight reduction programme and sleeve gastrectomy (when indicated and preferred by the patient) aiming to achieve greater than 10% weight reduction from baseline (intervention group) or standard post-ablation medical care (control group). Two-week continuous ECG monitoring will be used 3 and 18 months after CA to assess the arrhythmia burden. Other investigations will include transthoracic echocardiography with quantification of epicardial adipose tissue, and markers of low-grade inflammation and circulating adipokines.

Planned outcomes: The main objective is to assess the effect of complex weight-reducing interventions on the arrhythmia burden and quality of life. Subgroup analyses to identify patient subgroups preferentially benefiting from weight loss related to a decrease in arrhythmia burden will be performed. Exploratory objectives will include investigation of potential mechanisms linking weight reduction with amelioration of arrhythmia burden such as changes in markers of low-grade inflammation, circulating adipokines, cytokines, monocytes or reduction of epicardial adipose tissue volume.

Trial registration: NCT04560387.

Keywords: Atrial fibrillation; Bariatric surgery; Low-grade inflammation; Obesity; Sleeve gastrectomy; Weight reduction.

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Figures

Fig. 1
Fig. 1
Study flowchart. Altogether four study visits are planned: baseline and months 3, 12 and 18. AF atrial fibrillation, BMI body mass index, ECG electrocardiogram
See this image and copyright information in PMC

References

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