Prednisone for Heart Failure Patients With Hyperuricemia

Heart Failure, Hyperuricemia Clinical Trial

— PUSH-PATH-2  

Official title:

Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129764
• Other study ID #: PUSH-PATH 2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2013
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2018
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: August 31, 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Hyperuricemia
• Hyperuricemia

Intervention

Drug:
• Prednisone

• Allopurinol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum creatinine levels	Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks	2 weeks
Secondary	Change from baseline in uric acid levels	Change from baseline in uric acid levels at the end of study, i.e. 2 weeks	2 weeks
Secondary	Change from baseline in Cystatin C	Change from baseline in cystatin c at the end of study, i.e. 2 weeks.	2 weeks
Secondary	the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)	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)	2 weeks
Secondary	The levels of angiotensin II and aldosterone in the circulation.	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)	2 weeks
Secondary	Daily urine output	24-hour urine output at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)	2 weeks
Secondary	New York Heart Association (NYHA) functional class	Change of NHHA functional class at the end of study	2 weeks
Secondary	24h urinary sodium excretion	24-hour urinary sodium excretion at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)	2 weeks