Cardiovascular EventsNCT03391128
Circulating P3NP and Cardiovascular Events in Hemodialysis Patients
An observational study of Cardiovascular Events and Cardiac Fibrosis, run by Toujinkai Hospital at 1 site in Japan.
Trial summary
This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Events, Cardiac Fibrosis
- How many people
- 244 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jan 2005to 31 Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Cardiovascular Events, Cardiac Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 1, 2005 to January 31, 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Jan 2005
- Primary completion31 Jan 2005
- Study completion31 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toujinkai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masato Nishimura, MD, Toujinkai Hospital
- Investigators
- Masato Nishimura, MD, Principal investigator, Tojinkai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391128
- Sponsor's protocol ID
- P3NPhemodialysis
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Circulating Aminoterminal Propeptide of Type 3 Procollagen in Cardiovascular Events in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT03391128
- Acronym / sponsor ID
- P3NPhemodialysis
- Conditions
- Cardiovascular Events, Cardiac Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Toujinkai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Jan 2005 (actual)
- Study completion
- 31 Jan 2005 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masato Nishimura, MD principal investigator
Tojinkai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Events and Cardiac Fibrosis, run by Toujinkai Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: January 1, 2005 to January 31, 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.