Atrial Arrhythmia, Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, cardiopulmonary exercise testing, exercise capacity, echocardiography, holter monitoring, peak oxygen uptake
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.
Interventions
DIAGNOSTIC_TESTObservation group
Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement
Sponsors
General Hospital Of Thessaloniki Ippokratio
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation) 2. Age \> 18 years 3. Capability of providing written consent 4. Patients able to undergo cardiopulmonary exercise testing 5. Patients able to comply with the follow-up schedule of the study
Exclusion criteria
1. Patients with structural cardiomyopathy 2. Patients with congenital heart disease 3. Patients with permanent atrial fibrillation 4. Patients who have undergone atrial fibrillation ablation 5. Patients with implanted cardiac devices for primary or secondary prevention 6. Patients with recent (within the last month) acute coronary syndrome 7. Patients with heart failure with reduced ejection fraction (HFrEF) or end-stage renal disease 8. Patients with autoimmune diseases or active malignancies 9. Patients with uncontrolled thyroid disease 10. Patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues 11. Patients who present with contraindications for cardiopulmonary exercise testing 12. Patients unable to provide written consent 13. Patients with poor echocardiographic images 14. Patients unable to undergo spirometry 15. Patients unable to comply with the follow-up schedule of the study 16. Patients with uncontrolled hypertension 17. Patients who have undergone recent (within the last 2 months) surgery 18. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of new atrial fibrillation paroxysms | 2 months | The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of cardioversions | 2 months - 6 months - 12 months | In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous) |
| Total burden of premature atrial contractions | Baseline and 12 months | Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring |
| Total burden of premature ventricular contractions | Baseline and 12 months | Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring |
| Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring | Baseline and 12 months | Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring |
| Microvolt T-wave Alternans (TWA) | Baseline and 12 months | Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings |
| Heart rate turbulence (HRT) | Baseline and 12 months | 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 |
| Atrial fibrillation - related hospitalizations | 2 months - 6 months - 12 months | The total number of atrial fibrillation - related hospitalizations |
| Peak oxygen uptake (peak VO2) | Baseline | Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing |
| Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) | Baseline | Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing |
| Left atrial strain | Baseline and 12 months | Left atrial strain measured during echocardiographic study |
| Left ventricular global longitudinal strain (GLS) | Baseline and 12 months | Left ventricular global longitudinal strain (GLS) measured during echocardiographic study |
| Plasma biomarkers | Baseline and 12 months | Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI) |
| Time to first recurrence | 12 months | Time from baseline to first recurrence of atrial fibrillation |
| Deceleration capacity (DC) | Baseline and 12 months | (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). |
Countries
Greece
Contacts
Primary ContactChristodoulos E. Papadopoulos, PhD
Backup ContactAristi C. Boulmpou, MSc
Outcome results
None listed