Back to resultsPrednisone for Decompensated Congestive Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Suspended
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring decompensated heart failure, prednisone, diuretics, diuresis
Eligibility Criteria
Inclusion Criteria: Hospitalized with primary diagnosis of CHF Patients with normal cortical function LVEF <40% Significant fluid overload, defined as ≥ 2 of the following Enlarged liver or ascites Peripheral or sacral edema ( ≥ 2+) Jugular venous distention ≥ 10 cm Pulmonary rales, pleural effusion on chest x-ray or orthopnea Exclusion Criteria: Severe stenotic valvular disease Serum creatinine > 4 mg/dl Patient refusal Any signs of infection or any condition that would contraindicate an glucocorticoids use Poor controlled hypertension Poor controlled diabetes mellitus Active myocarditis Malignancy or other terminal illness
Sites / Locations
- The First Hospital of Hebei Medical University
Outcomes
Primary Outcome Measures
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
Secondary Outcome Measures
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
Full Information
NCT ID
NCT00369044
First Posted
August 28, 2006
Last Updated
April 7, 2009
Sponsor
Hebei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00369044
Brief Title
Prednisone for Decompensated Congestive Heart Failure
Official Title
Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Suspended
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hebei Medical University
4. Oversight
5. Study Description
Brief Summary
We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.
Detailed Description
Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
decompensated heart failure, prednisone, diuretics, diuresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
Secondary Outcome Measure Information:
Title
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized with primary diagnosis of CHF
Patients with normal cortical function
LVEF <40%
Significant fluid overload, defined as ≥ 2 of the following
Enlarged liver or ascites
Peripheral or sacral edema ( ≥ 2+)
Jugular venous distention ≥ 10 cm
Pulmonary rales, pleural effusion on chest x-ray or orthopnea
Exclusion Criteria:
Severe stenotic valvular disease
Serum creatinine > 4 mg/dl
Patient refusal
Any signs of infection or any condition that would contraindicate an glucocorticoids use
Poor controlled hypertension
Poor controlled diabetes mellitus
Active myocarditis
Malignancy or other terminal illness
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
17086096
Citation
Liu C, Chen H, Zhou C, Ji Z, Liu G, Gao Y, Tian L, Yao L, Zheng Y, Zhao Q, Liu K. Potent potentiating diuretic effects of prednisone in congestive heart failure. J Cardiovasc Pharmacol. 2006 Oct;48(4):173-6. doi: 10.1097/01.fjc.0000245242.57088.5b.
Results Reference
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Prednisone for Decompensated Congestive Heart Failure
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