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Prednisone for Decompensated Congestive Heart Failure

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369044
First Posted: August 29, 2006
Last Update Posted: April 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hebei Medical University
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00369044     History of Changes
Other Study ID Numbers: 200608A
First Submitted: August 28, 2006
First Posted: August 29, 2006
Last Update Posted: April 8, 2009
Last Verified: June 2007

Keywords provided by Hebei Medical University:
decompensated heart failure
prednisone
diuretics
diuresis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents