The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

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

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

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Disorders Associated With Peritoneal Dialysis

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Peritoneal dialysis patients with hyperuricemia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum uric acid	blood test for serum uric acid	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)	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

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Investigators: Study Chair: Ling Wang, MD, PhD, Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 13, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: peritoneal dialysis; cardiovascular; Febuxostat; hyperuricemia
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: FPD2015