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CompletedNCT03391128Updated Jan 8, 2018

Circulating P3NP and Cardiovascular Events in Hemodialysis Patients

An observational study in Cardiovascular Events and Cardiac Fibrosis, sponsored by Toujinkai Hospital. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2018-01-08.

Sponsored by Toujinkai Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
244
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Cardiovascular Events
  • Cardiac Fibrosis

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
244 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. Cardiovascular events

    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.

    Time frame: January 1, 2005 to January 31, 2011

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Study locations

1 site
  • Toujinkai Hospital
    Kyoto, 612-8026, Japan
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03391128
Lead sponsor
Toujinkai Hospital
Responsible party
Masato Nishimura, MD (Director of Cardiovascular division, Toujinkai Hospital) — Principal investigator
First posted
Jan 5, 2018
Start date
Jan 1, 2005
Primary completion
Jan 31, 2005
Completion
Jan 31, 2005
Last update
Jan 8, 2018

Study contacts

Masato Nishimura, MD
principal investigator · Tojinkai Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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