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OpenTrials
Completed

NCT Number: NCT03391128

Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

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

Completed

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Toujinkai Hospital

Kyoto, 612-8026, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Toujinkai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jan 5, 2018
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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