Atrial FibrillationHERA-FIBNCT03344237
hsTnT in Patients Admitted to the ED With Atrial Fibrillation in the Era of NOACs - Heidelberg Registry of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 14 Sep 2017to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017
Who may be able to join
- documented atrial fibrillation
- availability of at least one hsTnT measurement
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology, Angiology and Pneumology, Heidelberg University Hospital
Heidelberg, Baden-Wurttemberg, 69120
Mehrshad Vafaie, Dr.med.Dr.med.univ.
Kiril M Stoyanov, Dr.med.
About this study
Official title: High-Sensitivity Cardiac Troponin T in Patients Admitted to the Emergency Department With Atrial Fibrillation in the Era of Novel Oral Anticoagulants - Heidelberg Registry of Atrial Fibrillation
The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs).
- 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.
Vascular and non-vascular death
Measured: Follow up after at least 6 months
Nonfatal myocardial infarction
Measured: Follow up after at least 6 months
Stroke/systemic embolism
Measured: Follow up after at least 6 months
Secondary outcomes (1)
Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism
Measured: Follow up after at least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start14 Sep 2017
- Primary completion1 Nov 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.med. Dr.med.univ. Mehrshad VAFAIE, University Hospital Heidelberg
- Investigators
- Mehrshad Vafaie, Dr.med.Dr.med.univ., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344237
- Sponsor's protocol ID
- HERA-FIB
- Acronym
- HERA-FIB
- Status last verified
- Sep 2019
- First submitted
- 11 Nov 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Sensitivity Cardiac Troponin T in Patients Admitted to the Emergency Department With Atrial Fibrillation in the Era of Novel Oral Anticoagulants - Heidelberg Registry of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03344237
- Acronym / sponsor ID
- HERA-FIB / HERA-FIB
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
The purpose of the Heidelberg Registry of Atrial Fibrillation (HERA-FIB) is to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department in the era of novel oral anticoagulants (NOACs).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A cohort of approximately 5000 consecutive patients with atrial fibrillation presenting to the emergency department of the Heidelberg University Hospital between March 2013 and June 2017
Key inclusion criteria (2 listed)
- documented atrial fibrillation
- availability of at least one hsTnT measurement
Key exclusion criteria (1 listed)
- none
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
Vascular and non-vascular death
Time frame: Follow up after at least 6 months
Nonfatal myocardial infarction
Time frame: Follow up after at least 6 months
Stroke/systemic embolism
Time frame: Follow up after at least 6 months
1 secondary outcome
Stroke, systemic embolism, myocardial infarction, vascular death, non-vascular death, composite endpoint of vascular and non-vascular death, nonfatal MI, stroke/systemic embolism
Time frame: Follow up after at least 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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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. This study is not recruiting at the moment.
Mehrshad Vafaie, Dr.med.Dr.med.univ. principal investigator
University Hospital Heidelberg
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 University Hospital Heidelberg 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 1 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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehrshad Vafaie, Dr.med.Dr.med.univ. (00496221/56-8676, mehrshad.vafaie@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular and non-vascular death (time frame: Follow up after at least 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.