Prednisone for Decompensated Congestive Heart Failure - Full Text View

Sponsor:	Hebei Medical University
Information provided by:	Hebei Medical University
ClinicalTrials.gov Identifier:	NCT00369044

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: prednisone	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Hebei Medical University:

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

Estimated Enrollment:	60
Study Start Date:	October 2006
Estimated Study Completion Date:	July 2008

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369044

Locations

China, Hebei
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031

Sponsors and Collaborators

Hebei Medical University

Investigators

Principal Investigator:

Kunshen Liu, MD

The First Hospital of Hebei Medical University

More Information

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.

Study ID Numbers:	200608A
Study First Received:	August 28, 2006
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00369044 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Hebei Medical University:

decompensated heart failure
prednisone
diuretics
diuresis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Heart Failure
Heart Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Glucocorticoids
Hormones
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010