Prednisone for Heart Failure Patients With Hyperuricemia

Last updated: October 12, 2018
Sponsor: Hebei Medical University
Overall Status: Completed

Phase

2/3

Condition

Chest Pain

Congestive Heart Failure

Gout (Hyperuricemia)

Treatment

N/A

Clinical Study ID

NCT02129764
PUSH-PATH 2
  • Ages 18-80
  • All Genders

Study Summary

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 prednisone and allopurinol may have similar effect on uric acid (UA) lowering in symptomatic heart failure patients with hyperuricemia, but prednisone may be superior over allopurinol in renal function improvement. Thus the investigators design this randomized head to head study to test their hypothesis that prednisone is superior over allopurinol in renal function improvement despite their similar effect on UA lowering in heart failure patients with hyperuricemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • chronic congestive heart failure

  • 18-80 years old

  • NYHA Class II-IV

  • Serum uric acid > 7mg/dl

  • left ventricular ejection fraction ≤ 45%

Exclusion

Exclusion Criteria:

  • Acute gouty arthritis;

  • Any condition (other than heart failure) that could limit the use of prednisone orxanthine oxidase inhibitors;

  • Acute decompensated heart failure;

  • Any concurrent disease that likely limits life expectancy;

  • Active myocarditis, or an hypertrophic obstructive or restrictive cardiomyopathy;

  • Myocardial infarction, stroke, unstable angina, or cardiac surgery within the previous 3 months;

  • Indication for hemodialysis

  • Creatinine> 3.0 mg per deciliter at admission to the hospital

  • Uncontrolled systolic blood pressure > 140 mmHg

  • Known bilateral renal artery stenosis

  • Complex congenital heart disease

  • Any signs of infections

  • Enrollment in another clinical trial involving medical or device-based interventions

Study Design

Total Participants: 205
Study Start date:
December 01, 2013
Estimated Completion Date:
August 31, 2018

Study Description

Hyperuricemia in heart failure (HF) is linked to renal impairment, hemodynamic compromise, and inflammation. Hyperuricemic HF patients are characterized by worsening of renal function and fragile volume state, both of which restrict the use of non-steroidal anti-inflammatory drugs (NSAIDs) when treating concurrent inflammatory diseases. Recent small studies suggest that steroidal anti-inflammatory drug, prednisone, may have renal protective, UA lowering, and potentiating diuretic effects in hyperuricemic HF patients. However, general acceptance of prednisone as a treatment option for anti-inflammation therapy in patients with hyperuricemic HF requires more safety data. We therefore designed a randomized study to compare the safety and renal protective effects of short-term use of prednisone with allopurinol, a widely used xanthine oxidase inhibitor with a well-established safety profile in HF, in hyperuricemic HF patients.

Connect with a study center

  • Shijiazhuang, Hebei 050031
    China

    Site Not Available

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