Serial Measurements of Biomarker in Patients With Acute Decompensated Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital, Basel, Switzerland
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00514384
First received: August 8, 2007
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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


Condition
Acute Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Serial Biomarker Measurements in Patients With ADHF

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT [ Time Frame: Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: February 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with ADHF not requiering ICU

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514384

Contacts
Contact: Christian Mueller, MD 0041-61-2655826 muellerch@uhbs.ch

Locations
Switzerland
Cantonal Hospital Aarau Recruiting
Aarau, Aargau, Switzerland
Contact: Beat Mueller, MD       beat.mueller@ksa.ch   
Hospital Wolhusen Recruiting
Wolhusen, Lucerne, Switzerland
Contact: Martin Peter, MD       martin.peter@ksl.ch   
University Hospital Basel Recruiting
Basel, Switzerland, 4032
Contact: Christian Mueller, MD    0041-61-2655826    muellerch@uhbs.ch   
University Hospital Lucerne Recruiting
Lucerne, Switzerland, 6000
Contact: Paul Erne, MD    041 205 11 11    karin.durrer@luks.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Mueller Christian, MD University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00514384     History of Changes
Other Study ID Numbers: Serial Biomarker in ADHF
Study First Received: August 8, 2007
Last Updated: May 13, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014