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Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514384
First Posted: August 9, 2007
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
  Purpose
Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy monitoring in patients presenting with acute decompensated heart failure.

Condition
Acute Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Serial Biomarker Measurements in Patients With ADHF

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT [ Time Frame: Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge ]

Enrollment: 350
Study Start Date: February 2007
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Background: Heart failure (HF) is a chronic and progressive illness resulting from a variety of cardiac causes, including ischemic and valvular heart disease, dilatative cardiomyopathy or hypertension. HF may also develop suddenly, particularly as a complication of acute myocardial infarction or as an acute exacerbation in patients with previously compensated chronic HF. Diagnosis and in-hospital management of HF is often demanding and outcome especially regarding rehospitalizations is impaired. Novel biomarker may be very helpful in assessment of diagnosis, prognosis, and severity of HF as well as for treatment monitoring.

Design: Prospective, multicenter observational study Setting: University Hospital Basel, Kantonsspital Aarau, Kantonsspital Luzern, Kantonsspital Wolhusen Patients: Patients with acute HF not requiring ICU admission

Measurement of serial biomarker (BNP, NT-proBNP, MR-proADM, ST2, hs-cTnI and Copeptin) will be performed at presentation, at 6 hours (h), 12h, 18h, 24h, at 48h, at day 6 and at hospital discharge. Follow- up will be performed at 6 Month, 1 year and 2 years.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with ADHF not requiering ICU
Criteria

Inclusion Criteria:

  • Acute HF
  • Informed consent

Exclusion Criteria:

  • Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514384


Locations
Switzerland
Cantonal Hospital Aarau
Aarau, Aargau, Switzerland
Hospital Wolhusen
Wolhusen, Lucerne, Switzerland
University Hospital Basel
Basel, Switzerland, 4031
University Hospital Lucerne
Lucerne, Switzerland, 6000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mueller Christian, MD University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00514384     History of Changes
Other Study ID Numbers: Serial Biomarker in ADHF
First Submitted: August 8, 2007
First Posted: August 9, 2007
Last Update Posted: December 3, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases