Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)

Conditions
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Atrial Fibrillation, Atrial Arrhythmia

Intervention / Treatment
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* Diagnostic Test: Observation group


Participation Criteria
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Eligibility Criteria
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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 Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group<br>Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm | Diagnostic Test: Observation group<br>* Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new atrial fibrillation paroxysms | The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit. | 2 months | 
| Number of new atrial fibrillation paroxysms | The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit. | 6 months | 
| Number of new atrial fibrillation paroxysms | The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation - related hospitalizations | The total number of atrial fibrillation - related hospitalizations | 2 months - 6 months - 12 months | 
| Type of cardioversions | In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous) | 2 months - 6 months - 12 months | 
| Total burden of premature atrial contractions | Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring | Baseline and 12 months | 
| Total burden of premature ventricular contractions | Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring | Baseline and 12 months | 
| Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring | Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring | Baseline and 12 months | 
| Microvolt T-wave Alternans (TWA) | Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings | Baseline and 12 months | 
| Heart rate turbulence (HRT) | Heart rate turbulence (HRT) is the baroreflex-mediated short-term oscillation of cardiac cycle lengths after spontaneous ventricular premature complexes. Specialist software detects abnormal HRT in patients' 24-hour ambulatory electrocardiographic monitor recordings | Baseline and 12 months | 
| Deceleration capacity (DC) | (Heart rate) deceleration capacity is a measurement of autonomic nerve regulation in heart failure. Specialist software quantifies deceleration capacity, which is measured in milliseconds (ms). | Baseline and 12 months | 
| Peak oxygen uptake (peak VO2) | Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing | Baseline | 
| Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) | Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing | Baseline | 
| Left atrial strain | Left atrial strain measured during echocardiographic study | Baseline and 12 months | 
| Left ventricular global longitudinal strain (GLS) | Left ventricular global longitudinal strain (GLS) measured during echocardiographic study | Baseline and 12 months | 
| Plasma biomarkers | Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI) | Baseline and 12 months | 
| Time to first recurrence | Time from baseline to first recurrence of atrial fibrillation | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, cardiopulmonary exercise testing, exercise capacity, echocardiography, holter monitoring, peak oxygen uptake