Dose-comparison Study of Prednisone in Heart Failure

Hebei Medical University

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Drug: prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01559727

GL-2011-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Control

No Intervention group

Description:

The patients with symptomatic heart failure were treated with standard treatment.

15 mg prednisone group

Experimental group

Description:

The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.

Treatment:

Drug: prednisone

Drug: prednisone

Drug: prednisone

30 mg prednisone group

Experimental group

Description:

The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.

Treatment:

Drug: prednisone

Drug: prednisone

Drug: prednisone

60 mg prednisone group

Experimental group

Description:

The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.

Treatment:

Drug: prednisone

Drug: prednisone

Drug: prednisone