NCT01429857

Brief Summary

The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

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

June 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

1.6 years

First QC Date

February 1, 2011

Last Update Submit

June 13, 2013

Conditions

Heart Failure

Keywords

Troponin concentration in heart failure

Outcome Measures

Primary Outcomes (1)

  • Time to cardiovascular death or hospitalization

    6 Months Follow-Up

Secondary Outcomes (1)

  • Time to all cause death or hospitalization

    6 Months Follow-Up

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Hospital admission for acute cardiac decompensation
  • Systolic and / or diastolic heart failure

You may not qualify if:

  • Myocardial infarction in the last 4 weeks
  • Serum creatinine \>2.5 mg/dl
  • Pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie

Homburg, Saarland, 66421, Germany

Location

Related Publications (1)

  • Poss J, Ukena C, Kindermann I, Ehrlich P, Fuernau G, Ewen S, Mahfoud F, Kriechbaum S, Bohm M, Link A. Angiopoietin-2 and outcome in patients with acute decompensated heart failure. Clin Res Cardiol. 2015 May;104(5):380-7. doi: 10.1007/s00392-014-0787-y. Epub 2014 Nov 19.

    PMID: 25408112DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Christian Ukena

Study Record Dates

First Submitted

February 1, 2011

First Posted

September 7, 2011

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

DE(1)