Long-term Prednisone Use for End-stage Heart Failure

Hebei Medical University

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Hyperuricemia

Heart Failure

Treatments

Drug: prednisone

Study type

Interventional

Funder types

Other

Identifiers

NCT02282683

hebmu 201312

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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
1. Progressive deterioration in renal function (e.g., rise in BUN and creatinine)
2. Weight loss without other cause (e.g., cardiac cachexia)
3. Intolerance to ACE inhibitors due to hypotension and/or worsening renal function
4. Intolerance to beta blockers due to worsening HF or hypotension
5. Frequent systolic blood pressure <90 mm Hg
6. 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
7. Progressive decline in serum sodium, usually to <133 mEq/L
8. 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