Association of PICP Serum Marker in Patients With LVSD

Systolic Dysfunction Clinical Trial

Official title:

Phase 1 Study of PICP Serum Marker of Myocardial Fibrosis and Diastolic Function in Patients With Systolic Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00232388
• Other study ID #: L06-006
• Status: Terminated
• Phase: Phase 1
• First received: October 3, 2005
• Last updated: October 6, 2015
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: October 2015
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine if the carboxy-terminal of procollagen type I (PICP) can be a useful marker of different degrees of myocardial fibrosis.

Description:

Abnormality of diastolic function, particularly a more advanced form known as restrictive tilling pattern, has been correlated with worse outcome in patients with systolic dysfunction associated with chronic heart failure or following an acute myocardial infarction. Recently, the severity of diastolic dysfunction has also been shown to predict the response to cardiac synchronization therapy for refractory heart failure due to systolic dysfunction.

Varying degree of diastolic dysfunction has been reported among patients with comparable severity of systolic dysfunction. The underlying mechanisms responsible for the observed discordance between systolic and diastolic dysfunction in these patients remains incompletely understood.

The carboxy-terminal of procollagen type I (PICP), a peptide that is cleaved from procollagen type I during the synthesis of fibril-forming collagen type I, has been associated with myocardial fibrosis. Myocardial fibrosis is a major determinant of both systolic and diastolic function of the heart. We hypothesize that differential degrees of myocardial fibrosis may be responsible for these discrepancies.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Evidence of left ventricular systolic dysfunction (measured LVEF% less than 35%) measured by echocardiography within the previous three months at the time of enrollment

2. Greater than or equal to 18 years of age

3. Greater than or equal to 110 pounds in weight

Exclusion Criteria:

1.Non-sinus rhythm at the time of enrollment

Study Design

N/A

Related Conditions & MeSH terms

• Systolic Dysfunction

Intervention

Procedure:
• Blood draw

Locations

Country	Name	City	State
United States	TTUHSC	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	There will be a significant relationship between the severity of diastolic dysfunction and PICP			No