Prednisone for Heart Failure Patients With Hyperuricemia

Phase 2

Completed

• Conditions: Heart Failure, Hyperuricemia
• Interventions: Drug: Prednisone; Drug: Allopurinol

• Registration Number: NCT02129764
• Lead Sponsor: Hebei Medical University

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Primary Completion: 2018-02
• Study Completion: 2018-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	Prednisone	Prednisone will be given 30mg/day for 2 weeks and then tapered off.
Allopurinol	Allopurinol	Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day.

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum creatinine levels	2 weeks	Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Cystatin C	2 weeks	Change from baseline in cystatin c at the end of study, i.e. 2 weeks.
the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)	2 weeks	Change of plasma TNF-alfa, IL-6, and hs-CRP levels at the end of study, i.e. 2 weeks (expressed as percentage of baseline)
The levels of angiotensin II and aldosterone in the circulation.	2 weeks	Change of plasma angiotensin II and aldosterone at end of week-1 (i.e. on day 7) and at the end of week-2 (i.e. on day 14), the values were expressed as percentage of baseline)
Change from baseline in uric acid levels	2 weeks	Change from baseline in uric acid levels at the end of study, i.e. 2 weeks
New York Heart Association (NYHA) functional class	2 weeks	Change of NHHA functional class at the end of study
24h urinary sodium excretion	2 weeks	24-hour urinary sodium excretion at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)
Daily urine output	2 weeks	24-hour urine output at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)