Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis

Last updated: February 17, 2022
Sponsor: Aristotle University Of Thessaloniki
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Cardiac Disease

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT05246423
29551/30.6.2020
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with paroxysmal atrial fibrillation (in sinus rhythm during baselineevaluation)
  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

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 renaldisease
  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 ormotility 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

Total Participants: 80
Study Start date:
December 10, 2020
Estimated Completion Date:
December 10, 2024

Study 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.

Connect with a study center

  • Ippokratio General Hospital

    Thessaloníki, Thessaloniki 54642
    Greece

    Active - Recruiting

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