Dose-comparison Study of Prednisone in Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: prednisone
* Drug: prednisone
* Drug: prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The patients with symptomatic heart failure were treated with standard treatment. | |
| Experimental: 15 mg prednisone group<br>The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day. | Drug: prednisone<br>* The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.<br>|
| Experimental: 30 mg prednisone group<br>The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day. | Drug: prednisone<br>* The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day<br>|
| Experimental: 60 mg prednisone group<br>The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day. | Drug: prednisone<br>* The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily urinary volumes | Daily urinary volumes will be monitored for 10 days. | 10 days | 
| Urinary sodium excretion | Daily sodium exretions will be assessed at baseline, day 5 and day 10. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of prednisone on renin angiotensin aldosterone system. | 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. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, diuresis, prednisone