Status:
UNKNOWN
Long-term Prednisone Use for End-stage Heart Failure
Lead Sponsor:
Hebei Medical University
Conditions:
Heart Failure
Hyperuricemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02282683
Start Date
December 1 2013
End Date
December 1 2017
Last Update
January 12 2017
Active Locations (1)
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1
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031