Clinical trial NCT05080712: Progression of Atrial Fibrillation in the Young
Official title: Progression of Atrial Fibrillation in the Young
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
progression
left atrial function
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2021-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with new onset atrial fibrillation within 12 months from inclusion

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.

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

Primary outcomes:
measure: Development of atrial fibrillation burden
timeFrame: change from baseline at 5 years
Secondary outcomes:
measure: Development of humoral measures of hemodynamic status
timeFrame: Change from baseline at 5 years
measure: Development of atrial electrocardiographic status
timeFrame: Change from baseline at 5 years
measure: Development of supraventricular ectopies
timeFrame: Change from baseline at 5 years
measure: Development of atrial fibrillation incident
timeFrame: Change from baseline at 5 years
measure: Development of echocardiographic status
timeFrame: Change from baseline at 5 years
measure: Development of left atrial systolic function by echocardiography
timeFrame: Change from baseline at 5 years
measure: Development of left atrial volume by echocardiography
timeFrame: Change from baseline at 5 years
measure: Development of left ventricular systolic function by echocardiographic
timeFrame: Change from baseline at 5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet Danderyds University Hospital
name: Piotr Sobocinski Doliwa, MD, PhD
role: STUDY_CHAIR
References: