Dose-comparison Study of Prednisone in Heart Failure
Information source: Hebei Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: prednisone (Drug); prednisone (Drug); prednisone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hebei Medical University Official(s) and/or principal investigator(s):
Kunshen Liu, MD, Principal Investigator, Affiliation: Hebei Medical University First Hospital
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.
Clinical Details
Official title: Randomized Dose-comparison Study of Prednisone in Patients With Symptomatic Heart Failure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Daily urinary volumesUrinary sodium excretion
Secondary outcome: The effect of prednisone on renin angiotensin aldosterone system.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
The First Hospital of Hebei Medical University, Shijiazhuang 050031, China
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China
Additional Information
Starting date: March 2012
Last updated: August 27, 2013
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