NCT00514384

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

5.8 years

First QC Date

August 8, 2007

Last Update Submit

December 2, 2014

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Course of BNP, NT-proBNP, MR-proADM, Copeptin, ST2, hsTnT

    Entry, 6h, 12h, 18h, 24h, 48h, 6 days, discharge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ADHF not requiering ICU

You may qualify if:

  • Acute HF
  • Informed consent

You may not qualify if:

  • Cardiogenic shock, ST-elevation myocardial infarction, or other clinical conditions that require immediate ICU admission or urgent PTCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cantonal Hospital Aarau

Aarau, Canton of Aargau, Switzerland

Location

University Hospital Lucerne

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Hospital Wolhusen

Wolhusen, Canton of Lucerne, Switzerland

Location

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 21208408DERIVED

Study Officials

  • Mueller Christian, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

CH(4)