Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of new atrial fibrillation paroxysms
研究概览
简要总结
An observational, prospective, cohort study aiming to assess the potential predictive role of cardiopulmonary exercise testing in the prognosis of paroxysmal atrial fibrillation, in combination with echocardiographic indices and plasma biomarker values.
详细描述
The "ParoxysmaL Atrial fibrillation prognosis based on Cardiopulmonary Exercise test data and novel echocardiographic and plasma BiOchemical indices" (PLACEBO) trial comprises an observational, prospective, single-center cohort study including patients with paroxysmal atrial fibrillation. All patients undergo clinical examination, detailed echocardiographic study, cardiopulmonary exercise testing (CPET) and 24-hour ambulatory echocardiographic monitoring (24-hour Holter monitoring), as well as measurement of a series of plasma biochemical indices. The study will examine the potential prognostic role of CPET variables (such as peak VO2) in the future recurrences of paroxysmal atrial fibrillation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation)
- •Age > 18 years
- •Capability of providing written consent
- •Patients able to undergo cardiopulmonary exercise testing
- •Patients able to comply with the follow-up schedule of the study
排除标准
- •Patients with structural cardiomyopathy
- •Patients with congenital heart disease
- •Patients with permanent atrial fibrillation
- •Patients who have undergone atrial fibrillation ablation
- •Patients with implanted cardiac devices for primary or secondary prevention
- •Patients with recent (within the last month) acute coronary syndrome
- •Patients with heart failure with reduced ejection fraction (HFrEF) or end-stage renal disease
- •Patients with autoimmune diseases or active malignancies
- •Patients with uncontrolled thyroid disease
- •Patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues
- •Patients who present with contraindications for cardiopulmonary exercise testing
- •Patients unable to provide written consent
- •Patients with poor echocardiographic images
- •Patients unable to undergo spirometry
- •Patients unable to comply with the follow-up schedule of the study
- •Patients with uncontrolled hypertension
- •Patients who have undergone recent (within the last 2 months) surgery
结局指标
主要结局
Number of new atrial fibrillation paroxysms
时间窗: 12 months
The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.
次要结局
- Peak oxygen uptake (peak VO2)(Baseline)
- Time to first recurrence(12 months)
- Atrial fibrillation - related hospitalizations(2 months - 6 months - 12 months)
- Type of cardioversions(2 months - 6 months - 12 months)
- Total burden of premature atrial contractions(Baseline and 12 months)
- Total burden of premature ventricular contractions(Baseline and 12 months)
- Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring(Baseline and 12 months)
- Microvolt T-wave Alternans (TWA)(Baseline and 12 months)
- Deceleration capacity (DC)(Baseline and 12 months)
- Left ventricular global longitudinal strain (GLS)(Baseline and 12 months)
- Plasma biomarkers(Baseline and 12 months)
- Heart rate turbulence (HRT)(Baseline and 12 months)
- Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)(Baseline)
- Left atrial strain(Baseline and 12 months)
研究者
Christodoulos Papadopoulos
Assistant Professor of Cardiology
Aristotle University Of Thessaloniki