跳至主要内容
临床试验/NCT04560387
NCT04560387招募中不适用

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

Martin Haluzik2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年9月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
2
主要终点
Atrial fibrillation burden

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Paroxysmal or persistent AF scheduled for primary RF ablation
  • BMI ≥30 kg/m2
  • Age 18-70 years
  • Informed consent to the study

排除标准

  • 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

结局指标

主要结局

Atrial fibrillation burden

时间窗: 18 months

Atrial fibrillation burden expressed as % of total monitoring time at final visit

次要结局

  • hsCRP(18 months)
  • Epicardial adipose tissue volume(18 months)
  • Number of AF episodes on 14-day Holter monitoring(18 months)
  • Concentration of atrial natriuretic peptide (ANP)(18 months)
  • Concentration of brain natriuretic peptide (BNP)(18 months)
  • Progressive reduction of AF burden between 12- and 18-month follow up visit(18 months)

研究者

发起方
Martin Haluzik
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Martin Haluzik

Prof. Martin Haluzik, DSc.

Institute for Clinical and Experimental Medicine

研究点 (2)

Loading locations...

相似试验

Effect of Complex Weight-reducing Interventions on... | 临床试验