Long-term Prednisone Use for End-stage Heart Failure

Phase 2

• Conditions: Heart Failure; Hyperuricemia
• Interventions: Drug: prednisone

• Registration Number: NCT02282683
• Lead Sponsor: Hebei Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-10-28
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Mortality within 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in serum uric acid	month 6 and month 12
Change from baseline in serum creatinine	month 6 and month 12
Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months	12
Survival time (defined as time to death) within 12 months	12 months

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China