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Prednisone for Decompensated Congestive Heart Failure

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00369044
First received: August 28, 2006
Last updated: April 7, 2009
Last verified: June 2007

August 28, 2006
April 7, 2009
October 2006
Not Provided
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
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.
Complete list of historical versions of study NCT00369044 on ClinicalTrials.gov Archive Site
Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
Same as current
Not Provided
Not Provided
 
Prednisone for Decompensated Congestive Heart Failure
Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Heart Failure, Congestive
Drug: prednisone
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
July 2008
Not Provided

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00369044
200608A
Not Provided
Not Provided
Hebei Medical University
Not Provided
Principal Investigator: Kunshen Liu, MD Hebei Medical University First Hospital
Hebei Medical University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP