Progression of Atrial Fibrillation in the Young (PRAY)

May 22, 2024 updated by: Piotr Sobocinski Doliwa, Karolinska Institutet
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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with new onset atrial fibrillation within 12 months from inclusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change from baseline at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from baseline at 5 years
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
Change from baseline at 5 years
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
Change from baseline at 5 years
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
Change from baseline at 5 years
Development of echocardiographic status
Time Frame: Change from baseline at 5 years
Change in the left atrial volume indexed (ml/m2)
Change from baseline at 5 years
Development of left atrial systolic function by echocardiography
Time Frame: Change from baseline at 5 years
Change in left atrial strain (%)
Change from baseline at 5 years
Development of left atrial volume by echocardiography
Time Frame: Change from baseline at 5 years
Change in left ventricular volume indexed (ml/m2)
Change from baseline at 5 years
Development of left ventricular systolic function by echocardiographic
Time Frame: Change from baseline at 5 years
Change in left ventricular ejection fraction (%)
Change from baseline at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Boeringer Ingelheim

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2021

Primary Completion (Estimated)

December 20, 2027

Study Completion (Estimated)

December 20, 2027

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-00992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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