Cohort Study for Atrial Fibrillation Risk Stratification

Atrial Fibrillation Clinical Trial

— AFHRI  

Official title:

An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442970
• Other study ID #: AFHRI
• Status: Recruiting
• Start date: June 2013
• Est. completion date: January 2030

Study information

• Verified date: May 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Renate B Schnabel, Prof.
• Email: r.schnabel[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 2030
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Department of Cardiology, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Assum I, Krause J, Scheinhardt MO, Muller C, Hammer E, Borschel CS, Volker U, Conradi L, Geelhoed B, Zeller T, Schnabel RB, Heinig M. Tissue-specific multi-omics analysis of atrial fibrillation. Nat Commun. 2022 Jan 21;13(1):441. doi: 10.1038/s41467-022-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident atrial fibrillation	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.	up to 4 years
Secondary	Myocardial infarction	Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis	up to 4 years
Secondary	Cardiovascular death	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	up to 4 years
Secondary	Heart failure	echocardiography including Doppler-flow measurement	up to 4 years

External Links

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