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PRAY: Progression of Atrial Fibrillation in the Young

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT05080712
Collaborator
Boeringer Ingelheim (Other)
100
Enrollment
1
Location
74.8
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Progression of Atrial Fibrillation in the Young
    Actual Study Start Date :
    Sep 25, 2021
    Anticipated Primary Completion Date :
    Dec 20, 2027
    Anticipated Study Completion Date :
    Dec 20, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Development of atrial fibrillation burden [change from baseline at 5 years]

      Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly

    Secondary Outcome Measures

    1. Development of humoral measures of hemodynamic status [Change from baseline at 5 years]

      Change in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)

    2. Development of atrial electrocardiographic status [Change from baseline at 5 years]

      Change in number of supraventricular ectopic beats per 24 h on long-term ECG Yearly

    3. Development of supraventricular ectopies [Change from baseline at 5 years]

      Change in numbers of supraventricular tachycardia runs of at least 20 beats per 24 h on long-term ECG yearly

    4. Development of atrial fibrillation incident [Change from baseline at 5 years]

      Change in numbers of atrial fibrillation episodes per 24 h on long-term ECG yearly

    5. Development of echocardiographic status [Change from baseline at 5 years]

      Change in the left atrial volume indexed (ml/m2)

    6. Development of left atrial systolic function by echocardiography [Change from baseline at 5 years]

      Change in left atrial strain (%)

    7. Development of left atrial volume by echocardiography [Change from baseline at 5 years]

      Change in left ventricular volume indexed (ml/m2)

    8. Development of left ventricular systolic function by echocardiographic [Change from baseline at 5 years]

      Change in left ventricular ejection fraction (%)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Atrial fibrillation

    • Diagnosis of atrial fibrillation within one year of inclusion

    Exclusion Criteria:

    • Duration of atrial fibrillation over one year.

    • Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Danderyd Hospital Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet
    • Boeringer Ingelheim

    Investigators

    • Study Chair: Piotr Sobocinski Doliwa, MD, PhD, Karolinska Institutet Danderyds University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Piotr Sobocinski Doliwa, Principal Investigator, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT05080712
    Other Study ID Numbers:
    • 2021-00992
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Piotr Sobocinski Doliwa, Principal Investigator, Karolinska Institutet
    atrial fibrillation
    progression
    left atrial function
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Disease Progression

    Study Results

    No Results Posted as of Oct 18, 2021