Clinical trial NCT00514384: Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure
Official title: Prognostic Value of Serial Biomarker Measurements in Patients With ADHF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ADHF not requiering ICU

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.

Eligibility 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

Primary outcomes:
measure: Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT
timeFrame: Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Cantonal Hospital Aarau
state: Aargau
city: Wolhusen
country: Switzerland
facility: Hospital Wolhusen
state: Lucerne
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Lucerne
country: Switzerland
facility: University Hospital Lucerne
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mueller Christian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noveanu M, Breidthardt T, Potocki M, Reichlin T, Twerenbold R, Uthoff H, Socrates T, Arenja N, Reiter M, Meissner J, Heinisch C, Stalder S, Mueller C. Direct comparison of serial B-type natriuretic peptide and NT-proBNP levels for prediction of short- and long-term outcome in acute decompensated heart failure. Crit Care. 2011;15(1):R1. doi: 10.1186/cc9398. Epub 2011 Jan 5.