Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

January 4, 2018 updated by: Masato Nishimura, MD, Toujinkai Hospital

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

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kyoto, Japan, 612-8026
        • Toujinkai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Of 302 patients who met the inclusion criteria, 58 patients were excluded based on the exclusion criteria. Consequently, 244 patients (126 men and 118 women; mean age, 64 ± 11 years; dialysis duration, 11.5 ± 7.8 years) were enrolled in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 1, 2005 to January 31, 2011

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Masato Nishimura, MD, Tojinkai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

January 31, 2005

Study Completion (Actual)

January 31, 2005

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P3NPhemodialysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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