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| Name | Class |
|---|---|
| General Hospital Of Thessaloniki Ippokratio | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation group | Diagnostic Test | Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with paroxysmal atrial fibrillation, at least 2 weeks after the last atrial fibrillation episode, are eligible for the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christodoulos E. Papadopoulos, PhD | Contact | 2310892343 | +30 | chrpapado@gmail.com |
| Aristi C. Boulmpou, MSc | Contact | 2310892343 | +30 | aristi_bou1993@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Aristi C. Boulmpou, MSc | Aristotle University of Thessaloniki, Greece | Principal Investigator |
| Christodoulos E. Papadopoulos, PhD | Aristotle University of Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ippokratio General Hospital | Recruiting | Thessaloniki | Thessaloniki | 54642 | Greece |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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40 ml plasma specimen (-80 grades Celcius)
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |