The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kun-shen Liu M.D., Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00953303
First received: August 3, 2009
Last updated: February 19, 2012
Last verified: February 2012

August 3, 2009
February 19, 2012
January 2009
September 2011   (final data collection date for primary outcome measure)
Cardiovascular mortality in the 30 days following randomization. [ Time Frame: 30 days following randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953303 on ClinicalTrials.gov Archive Site
  • Renal function [ Time Frame: on day 7 ] [ Designated as safety issue: Yes ]
  • physician assessed global clinical status [ Time Frame: on day 3 and day 7 ] [ Designated as safety issue: No ]
  • patient assessed dyspnea [ Time Frame: on day 3 and day 7. ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: on day 7 ] [ Designated as safety issue: Yes ]
  • Physicians'and patient's evaluation of change in global assessment following randomization [ Time Frame: on day 3 and day 7 ] [ Designated as safety issue: No ]
  • Patient's evaluation of change in dyspnea. [ Time Frame: on day 3 and day 7. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure

Evidence showed that glucocorticoids could induce potent diuretic actions and improve renal functions in patients with decompensated congestive heart failure. Thus we design this study to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days following randomization.

Newly emerging clinical evidence showed glucocorticoids, when added to best conventional therapy, could produce potent diuretic effects, and improve renal functions in patients with decompensated congestive heart failure. It holds ture even in the patients who failed to respond to high dose of furosemide (>200mg/day). The present study is to confirm the clinical efficacy of glucocorticoids on cardiovascular mortality in patients with decompensated congestive heart failure who are on best conventional therapy.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Drug: glucocorticoid
    One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.
    Other Name: Dexamethasone Sodium Phosphate; prednisone acetate tablets
  • Drug: standard care
    The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.
    Other Name: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine
  • Experimental: glucocorticoid
    Intervention: Drug: glucocorticoid
  • Active Comparator: Standard care
    Intervention: Drug: standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
January 2012
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with dyspnea at rest due to acutely decompensated CHF requiring hospitalization and intravenous therapy. The cardiac etiology for acutely decompensated CHF was established by echocardiogram and/or a chest x-ray film and 2 of the following:

    1. >2-pillow orthopnea before study entry
    2. Jugular venous distention and/or abdominal discomfort due to mesenteric congestion.

Patients may have had acute decompensation of chronic heart failure, gradual worsening of chronic heart failure, or new onset of acutely decompensated CHF. Patients who were receiving intravenous therapy i.e. Inotropic and/or vasodilator but who otherwise met entry criteria were also permitted into the study. Patients with signs of cardiac shock were also permitted into the study.

Exclusion Criteria:

  • Patient refusal
  • Any signs of infection
  • any condition that would contraindicate a glucocorticoids use
  • Poor controlled hypertension
  • Poor controlled diabetes mellitus
  • Active myocarditis
  • Malignancy or other terminal illness
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00953303
hebmu 08-12B
Yes
Kun-shen Liu M.D., Hebei Medical University
Hebei Medical University
Not Provided
Principal Investigator: Kunshen Liu, MD Hebei Medical University First Hospital
Hebei Medical University
February 2012

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