Atrial FibrillationPRAYNCT05080712
Progression of Atrial Fibrillation in the Young
An observational study of Atrial Fibrillation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2021to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with new onset atrial fibrillation within 12 months from inclusion
Who may be able to join
- Atrial fibrillation
- Diagnosis of atrial fibrillation within one year of inclusion
Who cannot join
- Duration of atrial fibrillation over one year.
- Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johan Engdahl, MD PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Danderyd Hospital
Stockholm
Piotr Sobocinski Doliwa, M.D. Ph.D., piotr.sobocinski-doliwa@sll.se
Johan Engdahl, johan.engdahl@sll.se
About this study
The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG
Read the detailed description
100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.
At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.
In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.
The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, progression, left atrial function
- Medical subject headings
- Atrial Fibrillation, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of atrial fibrillation burden
Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly
Measured: change from baseline at 5 years
Secondary outcomes (8)
Development of humoral measures of hemodynamic status
Change in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)
Measured: Change from baseline at 5 years
Development of atrial electrocardiographic status
Change in number of supraventricular ectopic beats per 24 h on long-term ECG Yearly
Measured: Change from baseline at 5 years
Development of supraventricular ectopies
Change in numbers of supraventricular tachycardia runs of at least 20 beats per 24 h on long-term ECG yearly
Measured: Change from baseline at 5 years
Development of atrial fibrillation incident
Change in numbers of atrial fibrillation episodes per 24 h on long-term ECG yearly
Measured: Change from baseline at 5 years
Development of echocardiographic status
Change in the left atrial volume indexed (ml/m2)
Measured: Change from baseline at 5 years
Development of left atrial systolic function by echocardiography
Change in left atrial strain (%)
Measured: Change from baseline at 5 years
Development of left atrial volume by echocardiography
Change in left ventricular volume indexed (ml/m2)
Measured: Change from baseline at 5 years
Development of left ventricular systolic function by echocardiographic
Change in left ventricular ejection fraction (%)
Measured: Change from baseline at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start25 Sep 2021
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (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 Karolinska InstitutetThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Piotr Sobocinski Doliwa, Karolinska Institutet
- Investigators
- Piotr Sobocinski Doliwa, MD, PhD, Study chair, Karolinska Institutet Danderyds University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080712
- Sponsor's protocol ID
- 2021-00992
- Acronym
- PRAY
- Status last verified
- May 2024
- First submitted
- 23 Sep 2021
- Last updated
- 23 May 2024
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Atrial Fibrillation in the Young
- ClinicalTrials.gov ID
- NCT05080712
- Acronym / sponsor ID
- PRAY / 2021-00992
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, progression, left atrial function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 18 Oct 2021 (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.
The purpose of this study is to investigate the presence and magnitude of structural changes of the heart and their long-term development in young patients with atrial Fibrillation (AF), studied by echocardiographic measurements and plasma biomarkers and their association to AF burden, studied using long-term ECG
Detailed description
100 patients with symptomatic Atrial Fibrillation diagnosis are included. Diagnosis is set either at the index visit or within 12 months before inclusion. . The follow up period is 5 years. Patients presenting with AF in connection with acute infection, acute cardiac ischemia, surgery or thyroid disease are excluded. Further, AF patients with cardiomyopathies, known genetic diseases and congenital cardiac abnormalities are also excluded.
At inclusion patients undergo an in-depth interview regarding comorbidities, medication, previous treatments related to the AF diagnosis. In addition, baseline data for weight and height are collected.
In connection to inclusion the patients are asked leave venous bloodwork (Na, K, Creatinine, plasma Glucose and NTproB-Type Natriuretic Peptide). An echocardiographic exam is performed according to a prespecified protocol with special emphasis on the left atrial function and anatomy. This is followed by a continuous ECG recording for 14 days using BioTel ePatch. The ECG patch is later returned to a core facility by mail.
The patients´ are followed for five years and are asked to leave bloodwork and perform a 14-day ECG recording yearly. After these exams, a follow up phone call is placed to the patient aimed at documenting clinical progress related to symptoms, treatment and interventions. After 5 years follow up patients undergo a follow up echocardiographic exam in addition to yearly bloodwork and ECG recording. The patients´ clinical symptoms are treated at the clinician´s discretion according to current guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with new onset atrial fibrillation within 12 months from inclusion
Key inclusion criteria (2 listed)
- Atrial fibrillation
- Diagnosis of atrial fibrillation within one year of inclusion
Key exclusion criteria (2 listed)
- Duration of atrial fibrillation over one year.
- Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of atrial fibrillation burden
Time frame: change from baseline at 5 years
Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly
8 secondary outcomes
Development of humoral measures of hemodynamic status
Time frame: Change from baseline at 5 years
Development of atrial electrocardiographic status
Time frame: Change from baseline at 5 years
Development of supraventricular ectopies
Time frame: Change from baseline at 5 years
Development of atrial fibrillation incident
Time frame: Change from baseline at 5 years
Development of echocardiographic status
Time frame: Change from baseline at 5 years
Development of left atrial systolic function by echocardiography
Time frame: Change from baseline at 5 years
Development of left atrial volume by echocardiography
Time frame: Change from baseline at 5 years
Development of left ventricular systolic function by echocardiographic
Time frame: Change from baseline at 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Johan Engdahl, MD PhD contact
Piotr Sobocinski Doliwa, MD, PhD study chair
Karolinska Institutet Danderyds University Hospital
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, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 May 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Sobocinski Doliwa, M.D. Ph.D. (+46812357556, piotr.sobocinski-doliwa@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of atrial fibrillation burden (time frame: change from baseline at 5 years). 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 23 May 2024.