NCT05442970

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Jun 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2013Jan 2030

Study Start

First participant enrolled

June 1, 2013

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

13.6 years

First QC Date

June 29, 2022

Last Update Submit

May 10, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Myocardial infarction

    up to 4 years

  • Cardiovascular death

    up to 4 years

  • Heart failure

    up to 4 years

Eligibility Criteria

Age18 Years - 85 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details1/1 selection
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related 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/s41467-022-27953-1.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

sophisticated biobank including DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Renate B Schnabel, Prof.

    Department of Cardiology, University Medical Center Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renate B Schnabel, Prof.

CONTACT

Daniel Engler, MSc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 5, 2022

Study Start

June 1, 2013

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2030

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations