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NCT02338128 Clinical Trial

The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

Hyperuricemia Clinical Trial

Official title:
The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02338128
Other study ID # FPD2015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date January 2018

Study information
Verified date July 2019
Source Shanghai 10th People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.

Description:

Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events of patients, and compare and evaluate the changes of heart function, heart construction, serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat treatment.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Peritoneal dialysis for more than 3 months with hyperuricemia.

Exclusion Criteria:

1. Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)

2. Heart failure (stage IV, NYHA), unstable angina, acute stroke

3. Severe lung disease or cancer

4. unable to sign the informed consent form or disagree following-up.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization,heart surgery, or death caused by cardiovascular disease.) heart failure, myocardial infarction, unstable angina which need hospitalization,heart surgery, or death caused by cardiovascular disease. 1 year
Secondary Serum uric acid blood test for serum uric acid 1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month
Secondary cardiovascular function (Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide) Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide. 6 months
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