Shijiazhuang, Hebei, 050031, China
NCT Number: NCT02129764
Prednisone for Heart Failure Patients With Hyperuricemia
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.
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Notify MeKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Prednisone
DrugAllopurinol
DrugPrimary outcomes
-
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 outcomes
-
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
-
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.
-
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)
-
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)
-
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)
-
New York Heart Association (NYHA) functional class
Time frame: 2 weeks
Change of NHHA functional class at the end of study
-
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)
Sponsors and collaborators
Lead sponsor
Hebei Medical University
Other
Registry information
Official study title
Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
Acronym: PUSH-PATH-2
Important dates
- Study start
- 2013
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- May 2, 2014
- Registry last updated
- Oct 16, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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