Long-term Prednisone Use for End-stage Heart Failure

NCT ID: NCT02282683

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Heart Failure; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prednisone

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

Group Type: EXPERIMENTAL

prednisone

Intervention Type: DRUG

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

Control

Maximum tolerated guideline-directed medical therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prednisone

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

Intervention Type: DRUG

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kun-shen Liu M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Kunshen Liu, M.D.

Role: primary

ksliud@sohu.com

86 311 85617033

References

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.

Reference Type: BACKGROUND

PMID: 23395281 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17876376 (View on PubMed)

Other Identifiers

hebmu 201312

Identifier Type: -

Identifier Source: org_study_id