Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

NCT05246423 | Unknown

• 1 other identifier: 29551/30.6.2020
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Arrhythmia

Keywords

atrial fibrillation; cardiopulmonary exercise testing; exercise capacity; echocardiography; holter monitoring; peak oxygen uptake

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (14)

• Atrial fibrillation - related hospitalizations

  2 months - 6 months - 12 months

• Type of cardioversions

  2 months - 6 months - 12 months

• Total burden of premature atrial contractions

  Baseline and 12 months

• Total burden of premature ventricular contractions

  Baseline and 12 months

• Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring

  Baseline and 12 months

Study Arms (1)

Observation group

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

Diagnostic Test: Observation group

Interventions

Observation group DIAGNOSTIC_TEST

Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement

Observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with paroxysmal atrial fibrillation (in sinus rhythm during baseline evaluation)
• Age \> 18 years
• Capability of providing written consent
• Patients able to undergo cardiopulmonary exercise testing
• Patients able to comply with the follow-up schedule of the study

You may not qualify if:

• Patients with structural cardiomyopathy
• Patients with congenital heart disease
• Patients with permanent atrial fibrillation
• Patients who have undergone atrial fibrillation ablation
• Patients with implanted cardiac devices for primary or secondary prevention
• Patients with recent (within the last month) acute coronary syndrome
• Patients with heart failure with reduced ejection fraction (HFrEF) or end-stage renal disease
• Patients with autoimmune diseases or active malignancies
• Patients with uncontrolled thyroid disease
• Patients unable to undergo cardiopulmonary exercise testing due to disability or motility issues
• Patients who present with contraindications for cardiopulmonary exercise testing
• Patients unable to provide written consent
• Patients with poor echocardiographic images
• Patients unable to undergo spirometry
• Patients unable to comply with the follow-up schedule of the study

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• General Hospital Of Thessaloniki Ippokratio: collaborator

Study Sites (1)

Ippokratio General Hospital

Thessaloniki, Thessaloniki, 54642, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

40 ml plasma specimen (-80 grades Celcius)

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aristi C. Boulmpou, MSc

  Aristotle University of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

• Christodoulos E. Papadopoulos, PhD

  Aristotle University of Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christodoulos E. Papadopoulos, PhD

CONTACT

2310892343; chrpapado@gmail.com

Aristi C. Boulmpou, MSc

CONTACT

2310892343; aristi_bou1993@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 18, 2022
• Study Start: December 10, 2020
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

GR (1)