Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of new atrial fibrillation paroxysms
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of new atrial fibrillation paroxysms
Time Frame: 12 months
The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.
Secondary Outcomes
- 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)
Investigators
Christodoulos Papadopoulos
Assistant Professor of Cardiology
Aristotle University Of Thessaloniki