Back to resultsLong-term Prednisone Use for End-stage Heart Failure
Primary Purpose
Heart Failure, Hyperuricemia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The First Hospital of Hebei Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prednisone
Control
Arm Description
Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months.
Maximum tolerated guideline-directed medical therapy
Outcomes
Primary Outcome Measures
Mortality within 12 months
Secondary Outcome Measures
Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months
Survival time (defined as time to death) within 12 months
Change from baseline in serum uric acid
Change from baseline in serum creatinine
Full Information
NCT ID
NCT02282683
First Posted
October 28, 2014
Last Updated
January 11, 2017
Sponsor
Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02282683
Brief Title
Long-term Prednisone Use for End-stage Heart Failure
Official Title
Long-term Prednisone Use in Patients With Advanced Heart Failure (ACCF/AHA Stage D) and Hyperuricemia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Maximum tolerated guideline-directed medical therapy
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months
Primary Outcome Measure Information:
Title
Mortality within 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months
Time Frame
12
Title
Survival time (defined as time to death) within 12 months
Time Frame
12 months
Title
Change from baseline in serum uric acid
Time Frame
month 6 and month 12
Title
Change from baseline in serum creatinine
Time Frame
month 6 and month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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
Exclusion Criteria:
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
Facility Information:
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kunshen Liu, M.D.
Phone
86 311 85617033
Email
ksliud@sohu.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
23395281
Citation
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.
Results Reference
background
PubMed Identifier
17876376
Citation
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.
Results Reference
background
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Long-term Prednisone Use for End-stage Heart Failure
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