Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

Completed

• Conditions: Cardiovascular Events; Cardiac Fibrosis

• Registration Number: NCT03391128
• Lead Sponsor: Toujinkai Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2005-01-31
• Study Completion: 2005-01-31
• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-04
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	January 1, 2005 to January 31, 2011	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.

Trial Locations

Locations (1)

Toujinkai Hospital; 🇯🇵 Kyoto, Japan