Dose-comparison Study of Prednisone in Heart Failure

Phase 3

Completed

• Conditions: Heart Failure
• Interventions: Drug: prednisone

• Registration Number: NCT01559727
• Lead Sponsor: Hebei Medical University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mg prednisone group	prednisone	The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
60 mg prednisone group	prednisone	The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
30 mg prednisone group	prednisone	The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.

Primary Outcome Measures

Name	Time	Method
Daily urinary volumes	10 days	Daily urinary volumes will be monitored for 10 days.
Urinary sodium excretion	10 days	Daily sodium exretions will be assessed at baseline, day 5 and day 10.

Secondary Outcome Measures

Name	Time	Method
The effect of prednisone on renin angiotensin aldosterone system.	10 days	The effect of prednisone on patients' renin angiotensin aldosterone system, such as renin activity, plasma Ang I, plasma Ang II, and plasma aldosterone will be will be assessed on baseline, day 5 and day 10.

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, China