PUSH-PATH-2: Prednisone for Heart Failure Patients With Hyperuricemia

Sponsor

Hebei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02129764

Collaborator

(none)

205

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Hyperuricemia	Drug: Prednisone Drug: Allopurinol	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisone Prednisone will be given 30mg/day for 2 weeks and then tapered off.	Drug: Prednisone
Active Comparator: Allopurinol Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day.	Drug: Allopurinol

Arm

Intervention/Treatment

Experimental: Prednisone

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

Drug: Prednisone

Active Comparator: Allopurinol

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

Drug: Allopurinol

Outcome Measures

Primary Outcome Measures

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

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
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)
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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Shijiazhuang	Hebei	China	050031

Sponsors and Collaborators

Hebei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kun-shen Liu M.D., Professor, Hebei Medical University

ClinicalTrials.gov Identifier:

NCT02129764

Other Study ID Numbers:

PUSH-PATH 2

First Posted:

May 2, 2014

Last Update Posted:

Oct 16, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 16, 2018