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Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

NCT ID: NCT00514384

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mueller Christian, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Cantonal Hospital Aarau

Aarau, Canton of Aargau, Switzerland

Site Status

University Hospital Lucerne

Lucerne, Canton of Lucerne, Switzerland

Site Status

Hospital Wolhusen

Wolhusen, Canton of Lucerne, Switzerland

Site Status

University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 21208408 (View on PubMed)

Other Identifiers

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Serial Biomarker in ADHF

Identifier Type: -

Identifier Source: org_study_id