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Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis (PLACEBO)

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ClinicalTrials.gov Identifier: NCT05246423
Recruitment Status : Recruiting
First Posted : February 18, 2022
Last Update Posted : February 18, 2022
Sponsor:
Collaborator:
General Hospital Of Thessaloniki Ippokratio
Information provided by (Responsible Party):
Christodoulos Papadopoulos, 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.

Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Arrhythmia Diagnostic Test: Observation group

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : December 10, 2024
Estimated Study Completion Date : December 10, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Observation group
Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm
Diagnostic Test: Observation group
Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement




Primary Outcome Measures :
  1. Number of new atrial fibrillation paroxysms [ Time Frame: 2 months ]
    The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.

  2. Number of new atrial fibrillation paroxysms [ Time Frame: 6 months ]
    The primary outcome of the study is the total number of atrial fibrillation paroxysms within one year of baseline visit.

  3. Number of new atrial fibrillation paroxysms [ Time Frame: 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 :
  1. Atrial fibrillation - related hospitalizations [ Time Frame: 2 months - 6 months - 12 months ]
    The total number of atrial fibrillation - related hospitalizations

  2. Type of cardioversions [ Time Frame: 2 months - 6 months - 12 months ]
    In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous)

  3. Total burden of premature atrial contractions [ Time Frame: Baseline and 12 months ]
    Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring

  4. Total burden of premature ventricular contractions [ Time Frame: Baseline and 12 months ]
    Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring

  5. Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring [ Time Frame: Baseline and 12 months ]
    Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring

  6. Microvolt T-wave Alternans (TWA) [ Time Frame: Baseline and 12 months ]
    Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings

  7. Heart rate turbulence (HRT) [ Time Frame: 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

  8. Deceleration capacity (DC) [ Time Frame: 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).

  9. Peak oxygen uptake (peak VO2) [ Time Frame: Baseline ]
    Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing

  10. Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) [ Time Frame: Baseline ]
    Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing

  11. Left atrial strain [ Time Frame: Baseline and 12 months ]
    Left atrial strain measured during echocardiographic study

  12. Left ventricular global longitudinal strain (GLS) [ Time Frame: Baseline and 12 months ]
    Left ventricular global longitudinal strain (GLS) measured during echocardiographic study

  13. Plasma biomarkers [ Time Frame: Baseline and 12 months ]
    Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI)

  14. Time to first recurrence [ Time Frame: 12 months ]
    Time from baseline to first recurrence of atrial fibrillation


Biospecimen Retention:   Samples Without DNA
40 ml plasma specimen (-80 grades Celcius)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246423


Contacts
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Contact: Christodoulos E. Papadopoulos, PhD 2310892343 ext +30 chrpapado@gmail.com
Contact: Aristi C. Boulmpou, MSc 2310892343 ext +30 aristi_bou1993@yahoo.gr

Locations
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Greece
Ippokratio General Hospital Recruiting
Thessaloníki, Thessaloniki, Greece, 54642
Contact: Aristi C. Boulmpou, MSc    2310892343 ext +30    aristi_bou1993@yahoo.gr   
Principal Investigator: Christodoulos E. Papadoupoulos, PhD         
Principal Investigator: Aristi C. Boulmpou, MSc         
Sub-Investigator: Eva Pella, MD         
Sub-Investigator: Vassilios P. Vassilikos, PhD         
Sub-Investigator: Afroditi K. Boutou, PhD         
Sub-Investigator: Pantelis Sarafidis, PhD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
General Hospital Of Thessaloniki Ippokratio
Investigators
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Principal Investigator: Aristi C. Boulmpou, MSc Aristotle University of Thessaloniki, Greece
Principal Investigator: Christodoulos E. Papadopoulos, PhD Aristotle University of Thessaloniki, Greece
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Responsible Party: Christodoulos Papadopoulos, Assistant Professor of Cardiology, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT05246423    
Other Study ID Numbers: 29551/30.6.2020
First Posted: February 18, 2022    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christodoulos Papadopoulos, Aristotle University Of Thessaloniki:
atrial fibrillation
cardiopulmonary exercise testing
exercise capacity
echocardiography
holter monitoring
peak oxygen uptake
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes