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.
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 Type
OBSERVATIONAL
Enrollment
80
Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement
Ippokratio General Hospital
Thessaloniki, Thessaloniki, Greece
RECRUITINGNumber 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Atrial fibrillation - related hospitalizations
The total number of atrial fibrillation - related hospitalizations
Time frame: 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)
Time frame: 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
Time frame: Baseline and 12 months
Total burden of premature ventricular contractions
Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring
Time frame: Baseline and 12 months
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Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring
Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring
Time frame: Baseline and 12 months
Microvolt T-wave Alternans (TWA)
Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings
Time frame: 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
Time frame: 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).
Time frame: Baseline and 12 months
Peak oxygen uptake (peak VO2)
Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing
Time frame: Baseline
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing
Time frame: Baseline
Left atrial strain
Left atrial strain measured during echocardiographic study
Time frame: Baseline and 12 months
Left ventricular global longitudinal strain (GLS)
Left ventricular global longitudinal strain (GLS) measured during echocardiographic study
Time frame: Baseline and 12 months
Plasma biomarkers
Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI)
Time frame: Baseline and 12 months
Time to first recurrence
Time from baseline to first recurrence of atrial fibrillation
Time frame: 12 months