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Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

NCT03391128 — Completed, 244 participants, Toujinkai Hospital

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

RegistryNCT03391128
StatusCompleted
Study typeObservational
Enrollment244 (Actual)
SponsorToujinkai Hospital (Other)
ConditionsCardiovascular Events, Cardiac Fibrosis
Datesstart 2005-01-01, primary completion 2005-01-31, completion 2005-01-31, first posted 2018-01-05, last updated 2018-01-08
Locations1 site in Japan

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-Summary

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

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+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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
Toujinkai HospitalKyotoJapan

+Investigators

My Notes