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Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

This study is currently recruiting participants.
Verified September 2011 by University Hospital, Saarland
Sponsor:
Information provided by (Responsible Party):
Christian Ukena, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01429857
First received: February 1, 2011
Last updated: September 5, 2011
Last verified: September 2011
History of Changes
  Purpose

The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Time to cardiovascular death or hospitalization [ Time Frame: 6 Months Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to all cause death or hospitalization [ Time Frame: 6 Months Follow-Up ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Hospital admission for acute cardiac decompensation
  • Systolic and / or diastolic heart failure

Exclusion Criteria:

  • Myocardial infarction in the last 4 weeks
  • Serum creatinine >2.5 mg/dl
  • Pulmonary embolism
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429857

Locations
Germany
Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie Recruiting
Homburg, Saarland, Germany, 66421
Contact: Christian Ukena, Dr     00491733916169     christian.ukena@uks.eu    
Principal Investigator: Christian Ukena, Dr            
Sponsors and Collaborators
University Hospital, Saarland
  More Information

No publications provided

Responsible Party: Christian Ukena, Dr. med. Christian Ukena, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01429857     History of Changes
Other Study ID Numbers: Hom-AHF-Troponin
Study First Received: February 1, 2011
Last Updated: September 5, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Saarland:
Troponin concentration in heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013