Long-term Prednisone Use for End-stage Heart Failure

NCT02282683 | Unknown Phase 2

• 1 other identifier: hebmu 201312
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality within 12 months

  12 months

Secondary Outcomes (4)

• 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

• Change from baseline in serum uric acid

  month 6 and month 12

• Change from baseline in serum creatinine

  month 6 and month 12

Study Arms (2)

Prednisone

EXPERIMENTAL

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

Drug: prednisone

Control

NO INTERVENTION

Maximum tolerated guideline-directed medical therapy

Interventions

prednisone DRUG

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

Prednisone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 23395281 BACKGROUND

• 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.

  PMID: 17876376 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Hyperuricemia

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 4, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

CN (1)