Heart Failure, HyperuricemiaPhase 2/3PUSH-PATH-2NCT02129764
Prednisone for Heart Failure Patients With Hyperuricemia
A Phase 2/3 study testing Prednisone and Allopurinol in people with Heart Failure, Hyperuricemia, run by Hebei Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Hyperuricemia
- What is being tested?
- Prednisone and Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to 31 Aug 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic congestive heart failure
- 18-80 years old
- NYHA Class II-IV
- Serum uric acid > 7mg/dl
- left ventricular ejection fraction ≤ 45%
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
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.
Read the 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.
- Conditions
- Heart Failure, Hyperuricemia
- Being tested
- Prednisone, Allopurinol
- Medical subject headings
- Heart Failure, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
AllopurinolDrug
| Study group | Role | What they receive |
|---|---|---|
| Prednisone | Experimental | Prednisone will be given 30mg/day for 2 weeks and then tapered off. Receives: Drug: Prednisone |
| Allopurinol | Active comparator | Allopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day. Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum creatinine levels
Change from baseline in serum creatinine levels at the end of study, i.e. 2 weeks
Measured: 2 weeks
Secondary outcomes (7)
Change from baseline in uric acid levels
Change from baseline in uric acid levels at the end of study, i.e. 2 weeks
Measured: 2 weeks
Change from baseline in Cystatin C
Change from baseline in cystatin c at the end of study, i.e. 2 weeks.
Measured: 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)
Measured: 2 weeks
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)
Measured: 2 weeks
Daily urine output
24-hour urine output at week-1 (i.e. on day 7) and at week-2 (i.e. on day 14)
Measured: 2 weeks
New York Heart Association (NYHA) functional class
Change of NHHA functional class at the end of study
Measured: 2 weeks
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)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-shen Liu M.D., Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129764
- Sponsor's protocol ID
- PUSH-PATH 2
- Acronym
- PUSH-PATH-2
- Status last verified
- Oct 2018
- First submitted
- 30 Apr 2014
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone in Uric Acid Lowering in Symptomatic Heart Failure PATients With Hyperuricemia (PUSH-PATH Study 2)
- ClinicalTrials.gov ID
- NCT02129764
- Acronym / sponsor ID
- PUSH-PATH-2 / PUSH-PATH 2
- Conditions
- Heart Failure, Hyperuricemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone | Experimental | Drug: PrednisonePrednisone will be given 30mg/day for 2 weeks and then tapered off. |
| Allopurinol | Active comparator | Drug: AllopurinolAllopurinol will be given 100 mg/day initially, and then titrated to 200 mg/day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic congestive heart failure
- 18-80 years old
- NYHA Class II-IV
- Serum uric acid > 7mg/dl
- left ventricular ejection fraction ≤ 45%
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone | Drug | Prednisone |
| Allopurinol | Drug | Allopurinol |
Primary outcome
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
7 secondary outcomes
Change from baseline in uric acid levels
Time frame: 2 weeks
Change from baseline in Cystatin C
Time frame: 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
The levels of angiotensin II and aldosterone in the circulation.
Time frame: 2 weeks
Daily urine output
Time frame: 2 weeks
New York Heart Association (NYHA) functional class
Time frame: 2 weeks
24h urinary sodium excretion
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prednisone and Allopurinol in people with Heart Failure, Hyperuricemia, run by Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in serum creatinine levels (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.