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Progression of Atrial Fibrillation in the Young

Progression of Atrial Fibrillation in the Young

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05080712
Acronym
PRAY
Enrollment
100
Registered
2021-10-18
Start date
2021-09-25
Completion date
2027-12-20
Last updated
2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, progression, left atrial function

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

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.

Interventions

None listed

Sponsors

Boehringer Ingelheim
CollaboratorINDUSTRY
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Development of atrial fibrillation burdenchange from baseline at 5 yearsChange in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly

Secondary

MeasureTime frameDescription
Development of atrial electrocardiographic statusChange from baseline at 5 yearsChange in number of supraventricular ectopic beats per 24 h on long-term ECG Yearly
Development of supraventricular ectopiesChange from baseline at 5 yearsChange in numbers of supraventricular tachycardia runs of at least 20 beats per 24 h on long-term ECG yearly
Development of atrial fibrillation incidentChange from baseline at 5 yearsChange in numbers of atrial fibrillation episodes per 24 h on long-term ECG yearly
Development of humoral measures of hemodynamic statusChange from baseline at 5 yearsChange in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)
Development of left atrial systolic function by echocardiographyChange from baseline at 5 yearsChange in left atrial strain (%)
Development of left atrial volume by echocardiographyChange from baseline at 5 yearsChange in left ventricular volume indexed (ml/m2)
Development of left ventricular systolic function by echocardiographicChange from baseline at 5 yearsChange in left ventricular ejection fraction (%)
Development of echocardiographic statusChange from baseline at 5 yearsChange in the left atrial volume indexed (ml/m2)

Countries

Sweden

Contacts

Primary ContactPiotr Sobocinski Doliwa, M.D. Ph.D.
piotr.sobocinski-doliwa@sll.se+46812357556
Backup ContactJohan Engdahl, MD PhD
johan.engdahl@sll.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026