Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

Cardiovascular Events Clinical Trial

Official title:

Involvement of Circulating Aminoterminal Propeptide of Type 3 Procollagen in Cardiovascular Events in Patients on Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391128
• Other study ID #: P3NPhemodialysis
• Status: Completed
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 4, 2018
• Start date: January 1, 2005
• Est. completion date: January 31, 2005

Study information

• Verified date: January 2018
• Source: Toujinkai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.

Description:

Type III collagen abundantly exists in the cardiovascular system including the aorta and heart. The aminoterminal propeptide of type III procollagen (PIIINP) is an extension peptide of type III procollagen, which is cleaved off stoichiometrically during conversion from type III procollagen to type III collagen and liberated to serum. Elevated serum concentrations of PIIINP are considered a marker of higher collagen turnover and tissue fibrosis including the heart and vascular system. In this study, the investigators prospectively examined whether serum levels of PIIINP could be a biomarker for predicting cardiovascular events in hemodialysis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: January 31, 2005
• Est. primary completion date: January 31, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005

Exclusion Criteria:

• Histories of coronary events and/or interventions

• Congestive heart failure of New York Heart Association grades III to IV

• Moderate or worse valvular heart disease

• Permanent pacemaker implantation

• Idiopathic cardiomyopathy

• Chronic obstructive pulmonary disease

• Malignancy

• Acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus

Related Conditions & MeSH terms

• Cardiac Fibrosis
• Cardiovascular Events

Locations

Country	Name	City	State
Japan	Toujinkai Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Toujinkai Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	Cardiac deaths, non-fatal acute myocardial infarction, obstructive coronary artery disease needing intervention, vasospastic angina identified by angiography, heart failure needing hospitalization, bradycardia needing pacemaker implantation, dissecting aortic aneurysm, cardiac valvular disease needing valve replacement, peripheral artery disease needing bypass surgery or leg amputation.	January 1, 2005 to January 31, 2011