Heart FailurePhase 4NCT00919243
Prednisone for Heart Failure Patients With Hyperuricemia
A Phase 4 study testing prednisone and allopurinol in people with Heart Failure and 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 uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure, Hyperuricemia
- What is being tested?
- prednisone and allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Feb 2009to Aug 2010
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years old
- NYHA Class III-IV
- EF =< 40%
- Uric acid => 9.5 mg/dL
Who cannot join
- Acute gouty arthritis
- Any condition (other than CHF) that could limit the use of prednisone or allopurinol
- Any concurrent disease likely to limit life expectancy.
- Active myocarditis, or an obstructive or restrictive cardiomyopathy
- Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prednisone Versus Allopurinol for Symptomatic 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 uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could dramatically lower UA while improving renal function. Thus the investigators design this randomized head to head study to test our hypothesis that prednisone have the same efficacy to allopurinol on lowering UA and could improve renal function at the same time.
- Conditions
- Heart Failure, Hyperuricemia
- Being tested
- prednisone, allopurinol
- Keywords
- prednisone, allopurinol, heart failure, hyperuricemia
- 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
1 mg/kg/day with a maximum dose of 60 mg/day given orally
allopurinolDrug
allopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day.
| Study group | Role | What they receive |
|---|---|---|
| prednisone | Experimental | Not described Receives: Drug: prednisone |
| allopurinol | Active comparator | Not described Receives: Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in uric acid level
Measured: 4 weeks
Secondary outcomes (6)
Change from baseline in creatinine clearance rate
Measured: 4 weeks
Daily urine volume
Measured: 4 weeks
Body weight
Measured: 4 weeks
patient assessed dyspnea and physician assessed global clinical status
Measured: 4 weeks
6-minute walking distance
Measured: 4 weeks
NYHA functional class
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919243
- Sponsor's protocol ID
- hebmu 08-12
- Status last verified
- Jun 2009
- First submitted
- 11 Jun 2009
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu C, Zhao Q, Zhen Y, Gao Y, Tian L, Wang L, Ji L, Liu G, Ji Z, Liu K. Prednisone in Uric Acid lowering in Symptomatic Heart Failure Patients With Hyperuricemia (PUSH-PATH) study. Can J Cardiol. 2013 Sep;29(9):1048-54. doi: 10.1016/j.cjca.2012.11.008. Epub 2013 Feb 6.
PubMed 23395281
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Versus Allopurinol for Symptomatic Heart Failure Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT00919243
- Acronym / sponsor ID
- hebmu 08-12
- Conditions
- Heart Failure, Hyperuricemia
- Keywords
- prednisone, allopurinol, heart failure, hyperuricemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Jun 2009 (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 uric acid (UA) lowering therapy may improve clinical status in symptomatic heart failure patients with hyperuricemia. In their clinical practice, the investigators found that glucocorticoids could dramatically lower UA while improving renal function. Thus the investigators design this randomized head to head study to test our hypothesis that prednisone have the same efficacy to allopurinol on lowering UA and could improve renal function at the same time.
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: prednisone |
| allopurinol | Active comparator | Drug: allopurinol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-70 years old
- NYHA Class III-IV
- EF =< 40%
- Uric acid => 9.5 mg/dL
Key exclusion criteria (5 listed)
- Acute gouty arthritis
- Any condition (other than CHF) that could limit the use of prednisone or allopurinol
- Any concurrent disease likely to limit life expectancy.
- Active myocarditis, or an obstructive or restrictive cardiomyopathy
- Heart Attack, Stroke, Unstable Angina or Cardiac surgery within previous 3 months
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 |
|---|---|---|
| prednisone1 mg/kg/day with a maximum dose of 60 mg/day given orally | Drug | prednisone |
| allopurinolallopurinol, the dose of allopurinol is adjusted by patients' renal function, and with a maximum dose of 300mg/day. | Drug | allopurinol |
Primary outcome
Change from baseline in uric acid level
Time frame: 4 weeks
6 secondary outcomes
Change from baseline in creatinine clearance rate
Time frame: 4 weeks
Daily urine volume
Time frame: 4 weeks
Body weight
Time frame: 4 weeks
patient assessed dyspnea and physician assessed global clinical status
Time frame: 4 weeks
6-minute walking distance
Time frame: 4 weeks
NYHA functional class
Time frame: 4 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 1 Sep 2010.
- Derived from this study: PubMed 23395281Liu C, Zhao Q, Zhen Y, Gao Y, Tian L, Wang L, Ji L, Liu G, Ji Z, Liu K. Prednisone in Uric Acid lowering in Symptomatic Heart Failure Patients With Hyperuricemia (PUSH-PATH) study. Can J Cardiol. 2013 Sep;29(9):1048-54. doi: 10.1016/j.cjca.2012.11.008. Epub 2013 Feb 6.
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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 4 study testing prednisone and allopurinol in people with Heart Failure and 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 4 inclusion and 5 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 1 Sep 2010. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 uric acid level (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00919243, which also lists 1 linked publication.
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 1 Sep 2010.