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NCT Number: NCT05442970

Cohort Study for Atrial Fibrillation Risk Stratification

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

Recruiting

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location status: Recruiting

Location contact

Daniel Engler, MSc.

CONTACT

[email protected]

Renate B Schnabel, Prof.

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incident atrial fibrillation

    Time frame: 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 outcomes

  1. Myocardial infarction

    Time frame: up to 4 years

    Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis

  2. Cardiovascular death

    Time frame: 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

  3. Heart failure

    Time frame: up to 4 years

    echocardiography including Doppler-flow measurement

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Engler, MSc.

CONTACT

[email protected]

Renate B Schnabel, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: AFHRI

Important dates

Study start
2013
Primary completion
2027
Study completion
2030
First posted
Jul 5, 2022
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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