Prednisone for Heart Failure Patients With Hyperuricemia

NCT02129764 | Completed Phase 2 DMC

• 1 other identifier: PUSH-PATH 2
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change from baseline in uric acid levels

  2 weeks

• Change from baseline in Cystatin C

  2 weeks

• the levels of tumor necrosis factor (TNF) alfa,IL-6 in the circulation, high-sensitivity C-reactive Protein (hs-CRP)

  2 weeks

• The levels of angiotensin II and aldosterone in the circulation.

  2 weeks

• Daily urine output

  2 weeks

Study Arms (2)

Prednisone

EXPERIMENTAL

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

Drug: Prednisone

Allopurinol

ACTIVE COMPARATOR

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

Drug: Allopurinol

Interventions

Prednisone DRUG

Prednisone

Allopurinol DRUG

Allopurinol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic congestive heart failure
• years old
• NYHA Class II-IV
• Serum uric acid \> 7mg/dl
• left ventricular ejection fraction ≤ 45%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

Unknown Facility

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Heart Failure; Hyperuricemia

Interventions

Prednisone; Allopurinol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 2, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2018
• Study Completion: August 31, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

CN (1)