Clinical trial NCT04560387: Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
Official title: Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Obesity
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2020-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Atrial fibrillation burden
timeFrame: 18 months
Secondary outcomes:
measure: Number of AF episodes on 14-day Holter monitoring
timeFrame: 18 months
measure: Progressive reduction of AF burden between 12- and 18-month follow up visit
timeFrame: 18 months
measure: hsCRP
timeFrame: 18 months
measure: Epicardial adipose tissue volume
timeFrame: 18 months
measure: Concentration of atrial natriuretic peptide (ANP)
timeFrame: 18 months
measure: Concentration of brain natriuretic peptide (BNP)
timeFrame: 18 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
References:
citation: 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.