Progression of Atrial Fibrillation in the Young
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Development of atrial fibrillation burden [Time frame: change from baseline at 5 years]
Secondary outcome measures (8)
- Development of humoral measures of hemodynamic status [Time frame: Change from baseline at 5 years]
- Development of atrial electrocardiographic status [Time frame: Change from baseline at 5 years]
- Development of supraventricular ectopies [Time frame: Change from baseline at 5 years]
- Development of atrial fibrillation incident [Time frame: Change from baseline at 5 years]
- Development of echocardiographic status [Time frame: Change from baseline at 5 years]
- Development of left atrial systolic function by echocardiography [Time frame: Change from baseline at 5 years]
- Development of left atrial volume by echocardiography [Time frame: Change from baseline at 5 years]
- Development of left ventricular systolic function by echocardiographic [Time frame: Change from baseline at 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Danderyd Hospital — Stockholm
Identifiers
NCT: NCT05080712 · 2021-00992