The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

Completed

• Conditions: Disorders Associated With Peritoneal Dialysis; Hyperuricemia

• Registration Number: NCT02338128
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)	1 year	heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.

Secondary Outcome Measures

Name	Time	Method
Serum uric acid	1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month	blood test for serum uric acid
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)	6 months	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.

Trial Locations

Locations (1)

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China