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

• 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 ]

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.

• 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

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