Cohort Study for Atrial Fibrillation Risk Stratification

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05442970
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.

Detailed Description

The primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2022-06-29
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13
• Primary Completion: 2027-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Age 18 to 85 years;
• Personally signed informed consent

Exclusion Criteria

• Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation;
• Physical or psychological incapability to cooperate in the investigations

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incident atrial fibrillation	up to 4 years	12-lead Electrocardiogram (ECG) tracing, diagnosis of AF will be made if at least two cardiologists verify the rhythm abnormality using clinic visit, outside physician or hospital records, or ambulatory ECG reports.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	up to 4 years	if no other underlying cause of death is diagnosed: hypertension, coronary heart disease, other cardiovascular disease, atherosclerosis, diabetes mellitus, dyslipidemia, obesity, sudden death and cardiac symptoms
Myocardial infarction	up to 4 years	Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis
Heart failure	up to 4 years	echocardiography including Doppler-flow measurement

Trial Locations

Locations (1)

Department of Cardiology, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany