Prednisone for Heart Failure Patients With Hyperuricemia

NCT ID: NCT02129764

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2018-08-31

Brief 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.

Detailed 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.

Conditions

Heart Failure, Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prednisone

Prednisone will be given 30mg/day for 2 weeks and then tapered off.

Group Type: EXPERIMENTAL

Prednisone

Intervention Type: DRUG

Allopurinol

Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day.

Group Type: ACTIVE_COMPARATOR

Allopurinol

Intervention Type: DRUG

Interventions

Prednisone

Intervention Type: DRUG

Allopurinol

Intervention Type: DRUG

Eligibility Criteria

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 Criteria

• Acute gouty arthritis;
• Any condition (other than heart failure) that could limit the use of prednisone or xanthine 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kun-shen Liu M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

PUSH-PATH 2

Identifier Type: -

Identifier Source: org_study_id