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

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ClinicalTrials.gov Identifier: NCT02129764
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Kun-shen Liu M.D., 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.

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.

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Study Type : Interventional  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : August 31, 2018

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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



Primary Outcome Measures :
  1. Change from baseline in serum creatinine levels [ Time Frame: 2 weeks ]
    Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks


Secondary Outcome Measures :
  1. Change from baseline in uric acid levels [ Time Frame: 2 weeks ]
    Change from baseline in uric acid levels at the end of study, i.e. 2 weeks

  2. Change from baseline in Cystatin C [ Time Frame: 2 weeks ]
    Change from baseline in cystatin c at the end of study, i.e. 2 weeks.

  3. the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP) [ Time Frame: 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)

  4. The levels of angiotensin II and aldosterone in the circulation. [ Time Frame: 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)

  5. Daily urine output [ Time Frame: 2 weeks ]
    24-hour urine output at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)

  6. New York Heart Association (NYHA) functional class [ Time Frame: 2 weeks ]
    Change of NHHA functional class at the end of study

  7. 24h urinary sodium excretion [ Time Frame: 2 weeks ]
    24-hour urinary sodium excretion at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129764


Locations
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China, Hebei
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University

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Responsible Party: Kun-shen Liu M.D., Professor, Hebei Medical University
ClinicalTrials.gov Identifier: NCT02129764     History of Changes
Other Study ID Numbers: PUSH-PATH 2
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Heart Failure
Hyperuricemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Prednisone
Allopurinol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents