Overview

This trial is active, not recruiting.

Conditions disorders associated with peritoneal dialysis, hyperuricemia
Sponsor Shanghai 10th People's Hospital
Start date January 2015
End date January 2017
Trial size 50 participants
Trial identifier NCT02338128, FPD2015

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization,heart surgery, or death caused by cardiovascular disease.)
time frame: 1 year

Secondary Outcomes

Measure
Serum uric acid
time frame: 1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month
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)
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Shanghai 10th People's Hospital.