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Heart FailurePhase 2/3NCT02282683

Long-term Prednisone Use for End-stage Heart Failure

A Phase 2/3 study testing prednisone in people with Heart Failure and Hyperuricemia, run by Hebei Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year mortality. Currently, there was no evidence-based therapy such as mechanically assisted circulatory support available in China. 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
Dec 2013to Dec 2017
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

  • Repeated (>2) hospitalizations or ED visits for HF in the past year
  • Inability to exercise including exertion limited, exertion intolerance, resting symptoms or inotrope dependent
  • Left ventricular ejection fraction ≤35%
  • Serum uric acid level ≥500μmol/L
  • Received prednisone treatment during hospitalization period and And more 5 of the followings
  • Progressive deterioration in renal function (e.g., rise in BUN and creatinine)
Show all 13Show fewer
  • Weight loss without other cause (e.g., cardiac cachexia)
  • Intolerance to ACE inhibitors due to hypotension and/or worsening renal function
  • Intolerance to beta blockers due to worsening HF or hypotension
  • Frequent systolic blood pressure <90 mm Hg
  • Recent need to escalate diuretics to maintain volume status, often reaching daily furosemide equivalent dose >160 mg/d and/or use of supplemental thizide therapy
  • Progressive decline in serum sodium, usually to <133 mEq/L
  • Gastrointestinal symptoms (abdominal discomfort, nausea, poor appetite), disabling ascites, or severe lower-extremity edema

Who cannot join

  • Any condition (other than heart failure) that could limit the use of prednisone
  • 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
  • Uncontrolled systolic blood pressure > 160 mmHg
  • Complex congenital heart disease
  • Poorly controlled diabetes

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

    Kunshen Liu, M.D., 86 311 85617033, ksliud@sohu.com

    Recruiting

Other trials in China

About this study

Official title: Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia

Patients with advanced (ACCF/AHA stage D) heart failure and hyperuricemia have high one-year mortality. Currently, there was no evidence-based therapy such as mechanically assisted circulatory support available in China. The investigators found glucocorticoid treatment such as prednisone could improve cardiac performance, potentiate renal responsiveness to diuretics in such patients. Therefore, it could be used as bridge therapy to help ACE inhibitors or beta blocker titration. With its help, most of the patients with stage D heart failure could be titrated to higher dose of ACE inhibitors and beta blockers during hospitalization. However, the efficacy of long-term, low-dose of prednisone use in such patients with limited life expectancy remain unclear. Therefore, the investigators designed this study to observe whether putting low-dose of prednisone on the patients with stage D heart failure for long term could further improve their survival. All patients will receive prednisone treatment during hospitalization and receive maximum tolerated guideline-directed medical therapy (GDMT). After discharge from hospital, the patients will be randomized to receive long-term, low-dose prednisone treatment or standard GDMT.

Being tested
prednisone
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

    Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months

Study groups in NCT02282683
Study groupRoleWhat they receive
PrednisoneExperimentalPrednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months.
Receives: Drug: prednisone
ControlNo interventionMaximum tolerated guideline-directed medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality within 12 months

    Measured: 12 months

Secondary outcomes (4)

  1. Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months

    Measured: 12

  2. Survival time (defined as time to death) within 12 months

    Measured: 12 months

  3. Change from baseline in serum uric acid

    Measured: month 6 and month 12

  4. Change from baseline in serum creatinine

    Measured: month 6 and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282683
Sponsor's protocol ID
hebmu 201312
Status last verified
Jan 2017
First submitted
28 Oct 2014
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No

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

  • Liu C, Liu G, Zhou C, Ji Z, Zhen Y, Liu K. Potent diuretic effects of prednisone in heart failure patients with refractory diuretic resistance. Can J Cardiol. 2007 Sep;23(11):865-8. doi: 10.1016/s0828-282x(07)70840-1.

    PubMed 17876376

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing prednisone 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 13 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jan 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality within 12 months (time frame: 12 months). 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 NCT02282683, which also lists 2 linked publications.

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 12 Jan 2017.

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