Clinical trial NCT05246423: Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis
Official title: Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Atrial Arrhythmia
Keywords: atrial fibrillation
cardiopulmonary exercise testing
exercise capacity
echocardiography
holter monitoring
peak oxygen uptake
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: General Hospital Of Thessaloniki Ippokratio
First posted: 2022-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with paroxysmal atrial fibrillation, at least 2 weeks after the last atrial fibrillation episode, are eligible for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of new atrial fibrillation paroxysms
timeFrame: 2 months
measure: Number of new atrial fibrillation paroxysms
timeFrame: 6 months
measure: Number of new atrial fibrillation paroxysms
timeFrame: 12 months
Secondary outcomes:
measure: Atrial fibrillation - related hospitalizations
timeFrame: 2 months - 6 months - 12 months
measure: Type of cardioversions
timeFrame: 2 months - 6 months - 12 months
measure: Total burden of premature atrial contractions
timeFrame: Baseline and 12 months
measure: Total burden of premature ventricular contractions
timeFrame: Baseline and 12 months
measure: Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring
timeFrame: Baseline and 12 months
measure: Microvolt T-wave Alternans (TWA)
timeFrame: Baseline and 12 months
measure: Heart rate turbulence (HRT)
timeFrame: Baseline and 12 months
measure: Deceleration capacity (DC)
timeFrame: Baseline and 12 months
measure: Peak oxygen uptake (peak VO2)
timeFrame: Baseline
measure: Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)
timeFrame: Baseline
measure: Left atrial strain
timeFrame: Baseline and 12 months
measure: Left ventricular global longitudinal strain (GLS)
timeFrame: Baseline and 12 months
measure: Plasma biomarkers
timeFrame: Baseline and 12 months
measure: Time to first recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Ippokratio General Hospital
state: Thessaloniki
Study officials:
affiliation: Aristotle University of Thessaloniki, Greece
name: Aristi C. Boulmpou, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University of Thessaloniki, Greece
name: Christodoulos E. Papadopoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: