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Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT00514384
Collaborator
(none)
350
Enrollment
4
Locations
94
Duration (Months)
87.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of serial measurement of novel biomarker for diagnosis, prognosis or therapy monitoring in patients presenting with acute decompensated heart failure.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prognostic Value of Serial Biomarker Measurements in Patients With ADHF
    Study Start Date :
    Feb 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT [Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Cantonal Hospital Aarau Aarau Aargau Switzerland
    2 Hospital Wolhusen Wolhusen Lucerne Switzerland
    3 University Hospital Basel Basel Switzerland 4031
    4 University Hospital Lucerne Lucerne Switzerland 6000

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Mueller Christian, MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT00514384
    Other Study ID Numbers:
    • Serial Biomarker in ADHF
    First Posted:
    Aug 9, 2007
    Last Update Posted:
    Dec 3, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Dec 3, 2014