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Clinical Trials/NCT03391128
NCT03391128CompletedNot Applicable

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

Toujinkai Hospital1 site in 1 country244 target enrollmentStarted: January 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
244
Locations
1
Primary Endpoint
Cardiovascular events

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Cardiovascular events

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Toujinkai Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Masato Nishimura, MD

Director of Cardiovascular division

Toujinkai Hospital

Study Sites (1)

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