Progression of Atrial Fibrillation in the Young
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT05080712
- Lead Sponsor
- Karolinska Institutet
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Atrial fibrillation
- Diagnosis of atrial fibrillation within one year of inclusion
- Duration of atrial fibrillation over one year.
- Acute stressor for atrial fibrillation such as: acute ischemic heart disease or infection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Development of echocardiographic status Change from baseline at 5 years Change in the left atrial volume indexed (ml/m2)
Development of left atrial systolic function by echocardiography Change from baseline at 5 years Change in left atrial strain (%)
Development of left ventricular systolic function by echocardiographic Change from baseline at 5 years Change in left ventricular ejection fraction (%)
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)
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
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
Development of left atrial volume by echocardiography Change from baseline at 5 years Change in left ventricular volume indexed (ml/m2)
Trial Locations
- Locations (1)
Danderyd Hospital
🇸🇪Stockholm, Sweden