Skip to main content
OpenTrials
Completed

NCT Number: NCT02338128

The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disorders Associated With Peritoneal Dialysis Hyperuricemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peritoneal dialysis for more than 3 months with hyperuricemia.

Exclusion criteria

  • Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)
  • Heart failure (stage IV, NYHA), unstable angina, acute stroke
  • Severe lung disease or cancer
  • unable to sign the informed consent form or disagree following-up.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

    heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.

Secondary outcomes

  1. Serum uric acid

    Time frame: 1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month

    blood test for serum uric acid

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2015
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.