Heart FailureNCT01429857
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
An observational study of Heart Failure, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Heart Failure
- How many people
- 304 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Jan 2012
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Hospital admission for acute cardiac decompensation
- Systolic and / or diastolic heart failure
Who cannot join
- Myocardial infarction in the last 4 weeks
- Serum creatinine >2.5 mg/dl
- Pulmonary embolism
Trial locations and contacts
1 site in 1 country.
Germany1 site
Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie
Homburg, Saarland, 66421
About this study
The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.
Read the detailed description
Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.
- Conditions
- Heart Failure
- Keywords
- Troponin concentration in heart failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cardiovascular death or hospitalization
Measured: 6 Months Follow-Up
Secondary outcomes (1)
Time to all cause death or hospitalization
Measured: 6 Months Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
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 Heart FailureStudies 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
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Ukena, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429857
- Sponsor's protocol ID
- Hom-AHF-Troponin
- Status last verified
- Jun 2013
- First submitted
- 1 Feb 2011
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Poss J, Ukena C, Kindermann I, Ehrlich P, Fuernau G, Ewen S, Mahfoud F, Kriechbaum S, Bohm M, Link A. Angiopoietin-2 and outcome in patients with acute decompensated heart failure. Clin Res Cardiol. 2015 May;104(5):380-7. doi: 10.1007/s00392-014-0787-y. Epub 2014 Nov 19.
PubMed 25408112
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT01429857
- Acronym / sponsor ID
- Hom-AHF-Troponin
- Conditions
- Heart Failure
- Keywords
- Troponin concentration in heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Sep 2011 (estimated)
- 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 this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.
Detailed description
Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Hospital admission for acute cardiac decompensation
- Systolic and / or diastolic heart failure
Key exclusion criteria (3 listed)
- Myocardial infarction in the last 4 weeks
- Serum creatinine >2.5 mg/dl
- Pulmonary embolism
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
Time to cardiovascular death or hospitalization
Time frame: 6 Months Follow-Up
1 secondary outcome
Time to all cause death or hospitalization
Time frame: 6 Months Follow-Up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2013.
- Derived from this study: PubMed 25408112Poss J, Ukena C, Kindermann I, Ehrlich P, Fuernau G, Ewen S, Mahfoud F, Kriechbaum S, Bohm M, Link A. Angiopoietin-2 and outcome in patients with acute decompensated heart failure. Clin Res Cardiol. 2015 May;104(5):380-7. doi: 10.1007/s00392-014-0787-y. Epub 2014 Nov 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure, run by University Hospital, Saarland 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 3 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: finished, as of the sponsor's last update on 14 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to cardiovascular death or hospitalization (time frame: 6 Months Follow-Up). 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 NCT01429857, 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 14 Jun 2013.