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Dose-comparison Study of Prednisone in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
prednisone
prednisone
prednisone
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, diuresis, prednisone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Hospital of Hebei Medical University
  • The First Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

15 mg prednisone group

30 mg prednisone group

60 mg prednisone group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 19, 2012
Last Updated
August 27, 2013
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01559727
Brief Title
Dose-comparison Study of Prednisone in Heart Failure
Official Title
Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, diuresis, prednisone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients with symptomatic heart failure were treated with standard treatment.
Arm Title
15 mg prednisone group
Arm Type
Experimental
Arm Description
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Arm Title
30 mg prednisone group
Arm Type
Experimental
Arm Description
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.
Arm Title
60 mg prednisone group
Arm Type
Experimental
Arm Description
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day
Primary Outcome Measure Information:
Title
Daily urinary volumes
Description
Daily urinary volumes will be monitored for 10 days.
Time Frame
10 days
Title
Urinary sodium excretion
Description
Daily sodium exretions will be assessed at baseline, day 5 and day 10.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
The effect of prednisone on renin angiotensin aldosterone system.
Description
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.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunshen Liu, MD
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
ZIP/Postal Code
050031
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25992918
Citation
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.
Results Reference
derived

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Dose-comparison Study of Prednisone in Heart Failure

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