Dose-comparison Study of Prednisone in Heart Failure
Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 heart-failure
Started Mar 2012
Shorter than P25 for phase_3 heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedAugust 28, 2013
August 1, 2013
10 months
March 19, 2012
August 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
The effect of prednisone on renin angiotensin aldosterone system.
10 days
Study Arms (4)
Control
NO INTERVENTIONThe patients with symptomatic heart failure were treated with standard treatment.
15 mg prednisone group
EXPERIMENTALThe patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
30 mg prednisone group
EXPERIMENTALThe patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day.
60 mg prednisone group
EXPERIMENTALThe patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day.
Interventions
The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
Eligibility Criteria
You may qualify if:
- hospitalized for symptomatic heart failure
- dyspnea at rest or with minimal activity
- NT-proBNP \> 1000pg/ml
- LVEF ≤ 40%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
Related Publications (1)
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.
PMID: 25992918DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kunshen Liu, MD
The First Hospital of Hebei Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 21, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
August 28, 2013
Record last verified: 2013-08