Prednisone for Heart Failure Patients With Hyperuricemia (PUSH-PATH-2)

Hebei Medical University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Heart Failure, Hyperuricemia

Treatments

Drug: Allopurinol

Drug: Prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT02129764

PUSH-PATH 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

205 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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