DUTCH Weight Control in Atrial Fibrillation Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 22
- 主要终点
- For all patients, the one-year rhythm outcome status is ranked according to severity, from the most severe to the least severe outcome, as follows: Arrhythmic death while on Vaughn-Williams class I or III (VW-I/III) anti-arrhythmic drugs (AAD) In Atrial fibrillation (AF) after pulmonary vein isolation (PVI) In AF and on VW-I/III AAD In AF and not on VW-I/III AAD In Sinus Rhythm (SR) after PVI In SR and on VW-I/III AAD In SR and not on VW-I/III AAD
研究概览
简要总结
The primary objective of this randomized controlled trial is to demonstrate superiority of once-weekly 2.4 mg semaglutide s.c. over placebo in achieving sinus rhythm at one year in patients with obesity and first detected, symptomatic persistent atrial fibrillation (AF).
详细描述
Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.
Objective: Quantify the effect of an innovative weight loss management on rhythm control.
Study design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.
Study population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.
Intervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF
- •Obesity, as defined as BMI ≥ 30 kg/m2, or BMI ≥27 kg/m2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)
- •Scheduled electrical cardioversion (ECV)
- •Written informed consent
排除标准
- •Permanent AF
- •Acute coronary syndrome <6 months
- •Severe (grade III) valvular disease
- •Heart failure NYHA class III-IV
- •Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)
- •Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy <12 months, as judged by the treating physician
- •Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.
- •Secondary AF due to thyrotoxicosis, infection (e.g. pneumonia) or post-cardiothoracic surgery
- •Current or previous treatment with amiodaron
- •HbA1c ≥ 48 mmol/L, <3 months prior to randomization
- •History of diabetes mellitus type 1 or 2
- •Prior bariatric surgery
- •Use of other anti-obesity medication, <3 months prior to enrollment
- •Contra-indication for, or prior use of a GLP1-receptor agonist
- •History of chronic pancreatitis or acute pancreatitis <6 months
结局指标
主要结局
For all patients, the one-year rhythm outcome status is ranked according to severity, from the most severe to the least severe outcome, as follows: Arrhythmic death while on Vaughn-Williams class I or III (VW-I/III) anti-arrhythmic drugs (AAD) In Atrial fibrillation (AF) after pulmonary vein isolation (PVI) In AF and on VW-I/III AAD In AF and not on VW-I/III AAD In Sinus Rhythm (SR) after PVI In SR and on VW-I/III AAD In SR and not on VW-I/III AAD
For all patients, the one-year rhythm outcome status is ranked according to severity, from the most severe to the least severe outcome, as follows: Arrhythmic death while on Vaughn-Williams class I or III (VW-I/III) anti-arrhythmic drugs (AAD) In Atrial fibrillation (AF) after pulmonary vein isolation (PVI) In AF and on VW-I/III AAD In AF and not on VW-I/III AAD In Sinus Rhythm (SR) after PVI In SR and on VW-I/III AAD In SR and not on VW-I/III AAD
The second primary endpoint of the trial is the occurrence of any of the following at or within 12 months after randomization Persistent AF on the ECG at the 12-month visit Catheter ablation for AF Arrhythmic death Any serious adverse event due to an anti-arrhythmic drug This second primary endpoint will be statistically assessed as a binary (yes/no) variable.
The second primary endpoint of the trial is the occurrence of any of the following at or within 12 months after randomization Persistent AF on the ECG at the 12-month visit Catheter ablation for AF Arrhythmic death Any serious adverse event due to an anti-arrhythmic drug This second primary endpoint will be statistically assessed as a binary (yes/no) variable.
次要结局
- Change in diastolic blood pressure, measured in mmHg (time frame: week 0 and 52).
- Change in AF related symptoms measured by the modified EHRA score between the index visit and at 12 months after the index visit.
- Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.
- Number of hospitalizations because of an AF recurrence.
- Number of unscheduled hospital visits because of adverse events of AAD.
- Number of scheduled electrical cardioversions.
- Number of unscheduled electrical cardioversions.
- Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).
- Total number of unscheduled cardioverions
- Change in waist circumference, measured in cm (time frame: week 0 and 52).
- Change in weight, measured in % and kg (time frame: week 0 and 52)
- Change in BMI, measured in kg/m2 (time frame: week 0 and 52).
- Change in systolic blood pressure, measured in mmHg (time frame: week 0 and 52).
- Change in HbA1c, measured in % and mmol/L (time frame: week 0 and 52)
- Change in lipids (total cholesterol, LDL, HDL and triglycerides), measured in mmol/L (time frame: week 0 and 52)
- Change in CRP, measured in mg/L (time frame: week 0 and 52).
- Change in NT-pro BNP, measured pmol/L (time frame: week 0 and 52)
- Change in work productivity measured by the Work Productivity and Activity Index, between the index visit and at 12 months after the index visit.
- Change in exercise motivation using the Behavioral Regulation and Exercise Questionnaire 2 between the index visit and at 12 months after the index visit.
- Difference in total cost of all healthcare expenditures related to the management of atrial fibrillation, in Euros.
研究者
Ron Pisters
Scientific
Stichting Rijnstate Ziekenhuis