Dose-comparison Study of Prednisone in Heart Failure

NCT ID: NCT01559727

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

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.

Conditions

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Heart Failure

Keywords

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heart failure diuresis prednisone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

15 mg prednisone group

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

Group Type EXPERIMENTAL

prednisone

Intervention Type DRUG

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

30 mg prednisone group

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

Group Type EXPERIMENTAL

prednisone

Intervention Type DRUG

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

60 mg prednisone group

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

Group Type EXPERIMENTAL

prednisone

Intervention Type DRUG

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

Interventions

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prednisone

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

Intervention Type DRUG

prednisone

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

Intervention Type DRUG

prednisone

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kun-shen Liu M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kunshen Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Locations

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The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

The First Hospital of Hebei Medical University

Shijiazhuang, , China

Site Status

Countries

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China

References

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Liu C, Zhao Q, Zhen Y, Zhai J, Liu G, Zheng M, Ma G, Wang L, Tian L, Ji L, Li L, Duan L, Liu K. Effect of Corticosteroid on Renal Water and Sodium Excretion in Symptomatic Heart Failure: Prednisone for Renal Function Improvement Evaluation Study. J Cardiovasc Pharmacol. 2015 Sep;66(3):316-22. doi: 10.1097/FJC.0000000000000282.

Reference Type DERIVED
PMID: 25992918 (View on PubMed)

Other Identifiers

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GL-2011-29

Identifier Type: -

Identifier Source: org_study_id