Atrial FibrillationPLACEBONCT05246423
Ergospirometry in Paroxysmal Atrial Fibrillation Prognosis
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Arrhythmia
- What is being tested?
- Observation group
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 10 Dec 2020to 10 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with paroxysmal atrial fibrillation, at least 2 weeks after the last atrial fibrillation episode, are eligible for the study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
- Patients with uncontrolled hypertension
- Patients who have undergone recent (within the last 2 months) surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Ippokratio General Hospital
Thessaloniki, Thessaloniki, 54642
Aristi C. Boulmpou, MSc, 2310892343 ext. +30, aristi_bou1993@yahoo.gr
Christodoulos E. Papadoupoulos, PhD
About this study
Official title: Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Being tested
- Observation group
- Keywords
- atrial fibrillation, cardiopulmonary exercise testing, exercise capacity, echocardiography, holter monitoring, peak oxygen uptake
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation groupDiagnostic test
Patients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Patients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm Receives: Diagnostic Test: Observation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (14)
Atrial fibrillation - related hospitalizations
The total number of atrial fibrillation - related hospitalizations
Measured: 2 months - 6 months - 12 months
Type of cardioversions
In case of new atrial fibrillation paroxysms, the total number and type of cardioversions (electrical, pharmaceutical, spontaneous)
Measured: 2 months - 6 months - 12 months
Total burden of premature atrial contractions
Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring
Measured: Baseline and 12 months
Total burden of premature ventricular contractions
Total number of premature atrial contractions recorded during the 24-hour ambulatory electrocardiographic monitoring
Measured: Baseline and 12 months
Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring
Total atrial fibrillation episodes recorded 24-hour ambulatory electrocardiographic monitoring
Measured: Baseline and 12 months
Microvolt T-wave Alternans (TWA)
Specialist software quantifies microvolt TWA voltage in patients' 24-hour ambulatory electrocardiographic monitor recordings
Measured: Baseline and 12 months
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
Measured: Baseline and 12 months
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).
Measured: Baseline and 12 months
Peak oxygen uptake (peak VO2)
Peak oxygen uptake values, measured in ml/kg/min during cardiopulmonary exercise testing
Measured: Baseline
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope) measured during cardiopulmonary exercise testing
Measured: Baseline
Left atrial strain
Left atrial strain measured during echocardiographic study
Measured: Baseline and 12 months
Left ventricular global longitudinal strain (GLS)
Left ventricular global longitudinal strain (GLS) measured during echocardiographic study
Measured: Baseline and 12 months
Plasma biomarkers
Values of plasma biomarkers (GDF-15, IL-6, hs-cTnI)
Measured: Baseline and 12 months
Time to first recurrence
Time from baseline to first recurrence of atrial fibrillation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start10 Dec 2020
- Primary completion10 Dec 2024 (estimated)
- Study completion10 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital Of Thessaloniki Ippokratio
- Responsible party
- Principal investigator, Christodoulos Papadopoulos, Aristotle University Of Thessaloniki
- Investigators
- Aristi C. Boulmpou, MSc, Principal investigator, Aristotle University of Thessaloniki, GreeceChristodoulos E. Papadopoulos, PhD, Principal investigator, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246423
- Sponsor's protocol ID
- 29551/30.6.2020
- Acronym
- PLACEBO
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxysmal Atrial Fibrillation Prognosis Based on Cardiopulmonary Exercise Test Data and Novel Echocardiographic and Plasma Biochemical Indices (the PLACEBO Trial)
- ClinicalTrials.gov ID
- NCT05246423
- Acronym / sponsor ID
- PLACEBO / 29551/30.6.2020
- Conditions
- Atrial Fibrillation, Atrial Arrhythmia
- Keywords
- atrial fibrillation, cardiopulmonary exercise testing, exercise capacity, echocardiography, holter monitoring, peak oxygen uptake
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- General Hospital Of Thessaloniki Ippokratio
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Diagnostic Test: Observation groupPatients with paroxysmal atrial fibrillation, recruited at least two weeks after the last paroxysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal atrial fibrillation, at least 2 weeks after the last atrial fibrillation episode, are eligible for the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation groupPatients with paroxysmal atrial fibrillation undergo cardiopulmonary exercise testing, echocardiography, 24-hour ambulatory electrocardiographic monitoring and plasma biomarkers' measurement | Diagnostic test | Observation group |
Primary outcome
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.
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.
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.
14 secondary outcomes
Atrial fibrillation - related hospitalizations
Time frame: 2 months - 6 months - 12 months
Type of cardioversions
Time frame: 2 months - 6 months - 12 months
Total burden of premature atrial contractions
Time frame: Baseline and 12 months
Total burden of premature ventricular contractions
Time frame: Baseline and 12 months
Atrial fibrillation episodes during 24-hour ambulatory electrocardiographic monitoring
Time frame: Baseline and 12 months
Microvolt T-wave Alternans (TWA)
Time frame: Baseline and 12 months
Heart rate turbulence (HRT)
Time frame: Baseline and 12 months
Deceleration capacity (DC)
Time frame: Baseline and 12 months
Peak oxygen uptake (peak VO2)
Time frame: Baseline
Minute ventilation/carbon dioxide production slope (VE/VCO2 slope)
Time frame: Baseline
Left atrial strain
Time frame: Baseline and 12 months
Left ventricular global longitudinal strain (GLS)
Time frame: Baseline and 12 months
Plasma biomarkers
Time frame: Baseline and 12 months
Time to first recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aristi C. Boulmpou, MSc principal investigator
Aristotle University of Thessaloniki, Greece
Christodoulos E. Papadopoulos, PhD principal investigator
Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Arrhythmia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christodoulos E. Papadopoulos, PhD (2310892343 ext. +30, chrpapado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new atrial fibrillation paroxysms (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.