Prognostic Relevance of High-sensitivity Troponin in Pati... | NCT01429857

Studies
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

NCT01429857

Sponsor

University Hospital, Saarland

Status

Completed

Last Update Posted

Jun 14, 2013Estimated

Enrollment

304Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 1, 2011

First Submission Date that Met QC Criteria

Sep 5, 2011

First Posted Date

Sep 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2013

Last Update Posted Date

Jun 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Ukena, Dr. med. Christian Ukena, University Hospital, SaarlandPrincipal Investigator

Lead Sponsor

University Hospital, SaarlandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to cardiovascular death or hospitalization		6 Months Follow-Up

Secondary Outcomes

Measure	Description	Time Frame
Time to all cause death or hospitalization		6 Months Follow-Up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Innere Medizin III - Kardiologie, Angiologie und Internistische Intensivtherapie		Homburg	Saarland	66421	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25408112	Derived	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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases