Tissue Factor Expression in Stage C Heart Failure

NCT ID: NCT00935740

Last Updated: 2009-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-12-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Age-Matched Healthy Controls

Age-Matched Healthy Controls

No interventions assigned to this group

Heart Failure

Subjects with LVEF \< 40%

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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University of Utah

Principal Investigators

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Mark A Munger, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Other Identifiers

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TFHF

Identifier Type: -

Identifier Source: secondary_id

5809-96

Identifier Type: -

Identifier Source: org_study_id

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