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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Ukena, University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01429857
First received: February 1, 2011
Last updated: June 13, 2013
Last verified: June 2013
  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:


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 ]

Enrollment: 304
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429857

Locations
Germany
Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie
Homburg, Saarland, Germany, 66421
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: June 13, 2013
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 August 21, 2014