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NCT00514384 Clinical Trial

Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

Acute Heart Failure Clinical Trial

Official title:
Prognostic Value of Serial Biomarker Measurements in Patients With ADHF

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00514384
Other study ID # Serial Biomarker in ADHF
Secondary ID
Status Completed
Phase N/A
First received August 8, 2007
Last updated December 2, 2014
Start date February 2007
Est. completion date December 2014

Study information
Verified date December 2014
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date December 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Cantonal Hospital Aarau Aarau Aargau
Switzerland University Hospital Basel Basel
Switzerland University Hospital Lucerne Lucerne
Switzerland Hospital Wolhusen Wolhusen Lucerne

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge No
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