Progression of Atrial Fibrillation in the Young

Atrial Fibrillation Clinical Trial

— PRAY  

Official title:

Progression of Atrial Fibrillation in the Young

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05080712
• Other study ID #: 2021-00992
• Status: Recruiting
• Start date: September 25, 2021
• Est. completion date: December 20, 2027

Study information

• Verified date: May 2024
• Source: Karolinska Institutet
• Contact: Piotr Sobocinski Doliwa, M.D. Ph.D.
• Phone: +46812357556
• Email: piotr.sobocinski-doliwa[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 20, 2027
• Est. primary completion date: December 20, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Disease Progression

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Boeringer Ingelheim

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of atrial fibrillation burden	Change in burden of atrial fibrillation expressed as proportion of arrhythmia present on long-term ECG yearly	change from baseline at 5 years
Secondary	Development of humoral measures of hemodynamic status	Change in levels of plasma-N-terminal pro brain natriuretic peptide yearly (ng)	Change from baseline at 5 years
Secondary	Development of atrial electrocardiographic status	Change in number of supraventricular ectopic beats per 24 h on long-term ECG Yearly	Change from baseline at 5 years
Secondary	Development of supraventricular ectopies	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
Secondary	Development of atrial fibrillation incident	Change in numbers of atrial fibrillation episodes per 24 h on long-term ECG yearly	Change from baseline at 5 years
Secondary	Development of echocardiographic status	Change in the left atrial volume indexed (ml/m2)	Change from baseline at 5 years
Secondary	Development of left atrial systolic function by echocardiography	Change in left atrial strain (%)	Change from baseline at 5 years
Secondary	Development of left atrial volume by echocardiography	Change in left ventricular volume indexed (ml/m2)	Change from baseline at 5 years
Secondary	Development of left ventricular systolic function by echocardiographic	Change in left ventricular ejection fraction (%)	Change from baseline at 5 years