Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

Completed

• Conditions: Acute Heart Failure

• Registration Number: NCT00514384
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2012-12
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT	Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge

Trial Locations

Locations (4)

University Hospital Basel; 🇨🇭 Basel, Switzerland

Cantonal Hospital Aarau; 🇨🇭 Aarau, Aargau, Switzerland

Hospital Wolhusen; 🇨🇭 Wolhusen, Lucerne, Switzerland

University Hospital Lucerne; 🇨🇭 Lucerne, Switzerland