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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hebei Medical University First Hospital
  More Information

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

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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014