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The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT02338128
Recruitment Status : Unknown
Verified May 2016 by Ai Peng, Shanghai 10th People's Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : May 6, 2016
Sponsor:
Information provided by (Responsible Party):
Ai Peng, 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.

Condition or disease
Disorders Associated With Peritoneal Dialysis Hyperuricemia

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Febuxostat




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Peritoneal dialysis patients with hyperuricemia
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338128


Locations
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China, Shanghai
Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
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Study Chair: Ling Wang, MD, PhD Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital

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Responsible Party: Ai Peng, Chief of department of Nephrology & Rheumatology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02338128     History of Changes
Other Study ID Numbers: FPD2015
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016

Keywords provided by Ai Peng, Shanghai 10th People's Hospital:
peritoneal dialysis
hyperuricemia
cardiovascular
Febuxostat

Additional relevant MeSH terms:
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Hyperuricemia
Pathologic Processes
Febuxostat
Gout Suppressants
Antirheumatic Agents