Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

Atrial Fibrillation Clinical Trial

— PLACEBO  

Official title:

Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246423
• Other study ID #: 29551/30.6.2020
• Status: Recruiting
• Start date: December 10, 2020
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2022
• Source: Aristotle University Of Thessaloniki
• Contact: Christodoulos E. Papadopoulos, PhD
• Phone: 2310892343
• Email: chrpapado[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Arrhythmia
• Atrial Fibrillation

Intervention

Diagnostic Test:
• Observation group
Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement

Locations

Country	Name	City	State
Greece	Ippokratio General Hospital	Thessaloníki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	General Hospital Of Thessaloniki Ippokratio

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	Atrial fibrillation - related hospitalizations	The total number of atrial fibrillation - related hospitalizations	2 months - 6 months - 12 months
Secondary	Type of cardioversions	In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous)	2 months - 6 months - 12 months
Secondary	Total burden of premature atrial contractions	Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Secondary	Total burden of premature ventricular contractions	Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Secondary	Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring	Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring	Baseline and 12 months
Secondary	Microvolt T-wave Alternans (TWA)	Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings	Baseline and 12 months
Secondary	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
Secondary	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
Secondary	Peak oxygen uptake (peak VO2)	Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing	Baseline
Secondary	Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)	Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing	Baseline
Secondary	Left atrial strain	Left atrial strain measured during echocardiographic study	Baseline and 12 months
Secondary	Left ventricular global longitudinal strain (GLS)	Left ventricular global longitudinal strain (GLS) measured during echocardiographic study	Baseline and 12 months
Secondary	Plasma biomarkers	Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI)	Baseline and 12 months
Secondary	Time to first recurrence	Time from baseline to first recurrence of atrial fibrillation	12 months