Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
Overview
- Phase
- Phase 3
- Intervention
- prednisone
- Conditions
- Heart Failure
- Sponsor
- Hebei Medical University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Daily urinary volumes
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.
Detailed Description
Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.
Investigators
Kun-shen Liu M.D.
Professor
Hebei Medical University
Eligibility Criteria
Inclusion Criteria
- •hospitalized for symptomatic heart failure
- •dyspnea at rest or with minimal activity
- •NT-proBNP \> 1000pg/ml
- •LVEF ≤ 40%
Exclusion Criteria
- •any condition (other than CHF) that could limit the use of prednisone;
- •acute decompensated heart failure
- •active myocarditis
- •obstructive or restrictive cardiomyopathy
- •cardiac surgery within previous 3 months
- •acute coronary syndrome
Arms & Interventions
15 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Intervention: prednisone
30 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.
Intervention: prednisone
60 mg prednisone group
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
Intervention: prednisone
Outcomes
Primary Outcomes
Daily urinary volumes
Time Frame: 10 days
Daily urinary volumes will be monitored for 10 days.
Urinary sodium excretion
Time Frame: 10 days
Daily sodium exretions will be assessed at baseline, day 5 and day 10.
Secondary Outcomes
- The effect of prednisone on renin angiotensin aldosterone system.(10 days)