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NCT Number: NCT05080712

Progression of Atrial Fibrillation in the Young

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd Hospital

Stockholm, Sweden

Location status: Recruiting

Location contact

Johan Engdahl

CONTACT

[email protected]

Piotr Sobocinski Doliwa, M.D. Ph.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Development of humoral measures of hemodynamic status

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Change from baseline at 5 years

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

  6. Development of left atrial systolic function by echocardiography

    Time frame: Change from baseline at 5 years

    Change in left atrial strain (%)

  7. Development of left atrial volume by echocardiography

    Time frame: Change from baseline at 5 years

    Change in left ventricular volume indexed (ml/m2)

  8. Development of left ventricular systolic function by echocardiographic

    Time frame: Change from baseline at 5 years

    Change in left ventricular ejection fraction (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Engdahl, MD PhD

CONTACT

[email protected]

Piotr Sobocinski Doliwa, M.D. Ph.D.

CONTACT

[email protected]

+46812357556

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Acronym: PRAY

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 18, 2021
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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