Long-term Prednisone Use for End-stage Heart Failure

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02282683
• Other study ID #: hebmu 201312
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 28, 2014
• Last updated: January 11, 2017
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyperuricemia

Intervention

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

Locations

Country	Name	City	State
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 12 months		12 months	Yes
Secondary	Event-free survival time (defined as time to first hospitalization due to heart failure deterioration or death) within 12 months		12	Yes
Secondary	Survival time (defined as time to death) within 12 months		12 months	Yes
Secondary	Change from baseline in serum uric acid		month 6 and month 12	Yes
Secondary	Change from baseline in serum creatinine		month 6 and month 12	Yes