Prednisone for Decompensated Congestive Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00369044
• Other study ID #: 200608A
• Status: Suspended
• Phase: Phase 2/Phase 3
• First received: August 28, 2006
• Last updated: April 7, 2009
• Start date: October 2006
• Est. completion date: July 2008

Study information

• Verified date: June 2007
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• prednisone

Locations

Country	Name	City	State
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile