Atrial FibrillationAFHRINCT05442970
Cohort Study for Atrial Fibrillation Risk Stratification
An observational study of Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2013to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 to 85 years;
- Personally signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renate B Schnabel, Prof. contact
Daniel Engler, MSc. contact
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Renate B Schnabel, Prof., r.schnabel@uke.de
Daniel Engler, MSc., d.engler@uke.de
About this study
Official title: 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.
Read the 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).
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 4 years
Secondary outcomes (3)
Myocardial infarction
Typical rise and gradual fall (Troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis
Measured: up to 4 years
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
Measured: up to 4 years
Heart failure
echocardiography including Doppler-flow measurement
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study startJun 2013
- Primary completionJan 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renate B Schnabel, Prof., Principal investigator, Department of Cardiology, University Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442970
- Sponsor's protocol ID
- AFHRI
- Acronym
- AFHRI
- Status last verified
- May 2024
- First submitted
- 29 Jun 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Owing to propriety nature, supporting data cannot be made available openly. Further information about the data and access conditions is available uppon request
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.
PubMed 35064145
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals
- ClinicalTrials.gov ID
- NCT05442970
- Acronym / sponsor ID
- AFHRI / AFHRI
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 18 to 85 years;
- Personally signed informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Myocardial infarction
Time frame: up to 4 years
Cardiovascular death
Time frame: up to 4 years
Heart failure
Time frame: up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 35064145Assum 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.
- Individual participant dataSharing planned: Undecided. Owing to propriety nature, supporting data cannot be made available openly. Further information about the data and access conditions is available uppon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renate B Schnabel, Prof. contact
Daniel Engler, MSc. contact
Renate B Schnabel, Prof. principal investigator
Department of Cardiology, University Medical Center Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renate B Schnabel, Prof. (r.schnabel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident atrial fibrillation (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05442970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.