The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02338128

Enrollment

Registered

2015-01-14

Start date

2015-01-31

Completion date

2018-01-31

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders Associated With Peritoneal Dialysis, Hyperuricemia

Keywords

peritoneal dialysis, hyperuricemia, cardiovascular, Febuxostat

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results