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

Primary Purpose

Heart Failure, Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
Allopurinol
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Hyperuricemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prednisone

Allopurinol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in serum creatinine levels
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
Change from baseline in uric acid levels at the end of study, i.e. 2 weeks
Change from baseline in Cystatin C
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)
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.
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
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
Change of NHHA functional class at the end of study
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)

Full Information

First Posted
April 30, 2014
Last Updated
October 12, 2018
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02129764
Brief Title
Prednisone for Heart Failure Patients With Hyperuricemia
Acronym
PUSH-PATH-2
Official Title
Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Prednisone will be given 30mg/day for 2 weeks and then tapered off.
Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Description
Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Primary Outcome Measure Information:
Title
Change from baseline in serum creatinine levels
Description
Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in uric acid levels
Description
Change from baseline in uric acid levels at the end of study, i.e. 2 weeks
Time Frame
2 weeks
Title
Change from baseline in Cystatin C
Description
Change from baseline in cystatin c at the end of study, i.e. 2 weeks.
Time Frame
2 weeks
Title
the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)
Description
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)
Time Frame
2 weeks
Title
The levels of angiotensin II and aldosterone in the circulation.
Description
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)
Time Frame
2 weeks
Title
Daily urine output
Description
24-hour urine output at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)
Time Frame
2 weeks
Title
New York Heart Association (NYHA) functional class
Description
Change of NHHA functional class at the end of study
Time Frame
2 weeks
Title
24h urinary sodium excretion
Description
24-hour urinary sodium excretion at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China

12. IPD Sharing Statement

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Prednisone for Heart Failure Patients With Hyperuricemia

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