- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391128
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
Conditions
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
-
-
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Kyoto, Japan, 612-8026
- Toujinkai Hospital
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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.
Sponsor
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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