Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis (PLACEBO)

Aristotle University Of Thessaloniki

Status: Enrolling

Conditions: Atrial Fibrillation; Atrial Arrhythmia

Treatments: Diagnostic Test: Observation group

Study type: Observational

Funder types: Other

Identifiers

NCT05246423

29551/30.6.2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Observation group

Description:

Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm

Treatment:

Diagnostic Test: Observation group