Prednisone for Heart Failure Patients With Hyperuricemia

August 31, 2010 updated by: Hebei Medical University

Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia

Hyperuricemia is a very common finding in patients with heart failure. It is usually related to diuretic use and deteriorated renal function. The recently evidence showed that uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could dramatically lower UA while improving renal function. Thus the investigators design this randomized head to head study to test our hypothesis that prednisone have the same efficacy to allopurinol on lowering UA and could improve renal function at the same time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050031
        • Kunshen Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 years old
  • NYHA Class III-IV
  • EF =< 40%
  • Uric acid => 9.5 mg/dL

Exclusion Criteria:

  • Acute gouty arthritis
  • Any condition (other than CHF) that could limit the use of prednisone or allopurinol
  • Any concurrent disease likely to limit life expectancy.
  • Active myocarditis, or an obstructive or restrictive cardiomyopathy
  • Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prednisone
Drug: prednisone
1 mg/kg/day with a maximum dose of 60 mg/day given orally
ACTIVE_COMPARATOR: allopurinol
Drug: allopurinol
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in uric acid level
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 4 weeks
4 weeks
Change from baseline in creatinine clearance rate
Time Frame: 4 weeks
4 weeks
Daily urine volume
Time Frame: 4 weeks
4 weeks
patient assessed dyspnea and physician assessed global clinical status
Time Frame: 4 weeks
4 weeks
6-minute walking distance
Time Frame: 4 weeks
4 weeks
NYHA functional class
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

June 11, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (ESTIMATE)

June 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hebmu 08-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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