Cohort Study for Atrial Fibrillation Risk Stratification (AFHRI)

May 10, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Department of Cardiology, University Medical Center Hamburg-Eppendorf
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Outpatient cardiology sample at risk for AF. Recruitment in a single center design, at the Department of Cardiology, University Medical Center Hamburg-Eppendorf.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 years
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
up to 4 years
Heart failure
Time Frame: up to 4 years
echocardiography including Doppler-flow measurement
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Renate B Schnabel, Prof., Department of Cardiology, University Medical Center Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFHRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Owing to propriety nature, supporting data cannot be made available openly. Further information about the data and access conditions is available uppon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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