Prednisone for Decompensated Congestive Heart Failure
Information source: Hebei Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: prednisone (Drug)
Phase: Phase 2/Phase 3
Status: Suspended
Sponsored by: Hebei Medical University Official(s) and/or principal investigator(s):
Kunshen Liu, MD, Principal Investigator, Affiliation: The First Hospital of Hebei Medical University
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.
Clinical Details
Official title: Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
The First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, China
Additional Information
Related publications: 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.
Starting date: October 2006
Ending date: July 2008
Last updated: June 18, 2007
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