Tissue Factor Expression in Stage C Heart Failure | NCT00935740

Studies
Tissue Factor Expression in Stage C Heart Failure

NCT00935740

Sponsor

University of Utah

Status

Completed

Last Update Posted

Jul 9, 2009Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

Not provided

Countries

Not provided

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

ID	Type	Description	Link
TFHF

Status Module

Record Verification Date

Jul 2009

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

Dec 1996

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jun 18, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 9, 2009Estimated

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

Jul 7, 2009

Last Update Posted Date

Jul 9, 2009Estimated

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

Monocyte tissue factor (TF) was characterized in Class C heart failure (HF) vs. 25 age-matched volunteers. TF was 2.9 fold higher (p < 0.001) in HF patients vs. controls. HF patients showed increased clinical events (RR=1.29, p=0.04) when comparing procoagulant activity above/below median. HF is associated with increased TF expression.

Detailed Description

Previous studies suggest that markers of coagulation are elevated in heart failure (HF). Tissue factor (TF) plays the cardinal role in initiating the coagulation cascade. This study determines TF expression in HF and its association with disease progression.

Methods: Monocytes were obtained from 50 NYHA function class II-IV HF patients and 25 age-matched disease-free volunteers. TF protein, TF procoagulant activity, and tissue factor pathway inhibitor (TFPI) were determined.

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

Retention

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Age-Matched Healthy Controls		Age-Matched Healthy Controls
Heart Failure		Subjects with LVEF < 40%

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
This study determines TF expression in HF and its association with disease progression.		Hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart failure subjects with symptomatic heart failure (New York Heart Association [NYHA] functional class II to IV) due to either idiopathic dilated cardiomyopathy or ischemic cardiomyopathy and had a left ventricular ejection fraction < 0.35.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Heart failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark A Munger, Pharm.D.	University of Utah	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D013923	Thromboembolism
D019851	Thrombophilia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D016769	Embolism and Thrombosis
D014652	Vascular Diseases

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