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Recruiting NCT05442970

Cohort Study for Atrial Fibrillation Risk Stratification

Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Primary outcome measures

  • Incident atrial fibrillation [Time frame: up to 4 years]
Secondary outcome measures (3)
  • Myocardial infarction [Time frame: up to 4 years]
  • Cardiovascular death [Time frame: up to 4 years]
  • Heart failure [Time frame: up to 4 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Department of Cardiology, University Medical Center Hamburg-Eppendorf — Hamburg

Publications

  • 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. PMID 35064145

Identifiers

NCT: NCT05442970 · AFHRI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗