Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

Recruiting

• Conditions: Atrial Arrhythmia; Atrial Fibrillation
• Interventions: Diagnostic Test: Observation group

• Registration Number: NCT05246423
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Study Timeline

• Study Start: 2020-12-10
• Status Verified: 2022-02
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Study First Posted: 2022-02-18
• Last Update Posted: 2022-02-18
• Primary Completion: 2024-12-10
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation group	Observation group	Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm

Primary Outcome Measures

Name	Time	Method
Number of new atrial fibrillation paroxysms	12 months	The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.

Secondary Outcome Measures

Name	Time	Method
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 - related hospitalizations	2 months - 6 months - 12 months	The total number of atrial fibrillation - related hospitalizations
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
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
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).
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)
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
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
Peak oxygen uptake (peak VO2)	Baseline	Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing
Time to first recurrence	12 months	Time from baseline to first recurrence of atrial fibrillation

Trial Locations

Locations (1)

Ippokratio General Hospital; 🇬🇷 Thessaloníki, Thessaloniki, Greece