Dose-comparison Study of Prednisone in Heart Failure

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01559727

Enrollment

Registered

2012-03-21

Start date

2012-03-31

Completion date

2013-03-31

Last updated

2013-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, diuresis, prednisone

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.

Interventions

DRUGprednisone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026