Heart Failure
Conditions
Keywords
heart failure, prednisone, cardiovascular mortality, renal function
Brief summary
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.
Detailed description
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.
Interventions
DRUGglucocorticoid
One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.
DRUGstandard care
The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.
Sponsors
Hebei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality in the 30 days following randomization. | 30 days following randomization |
Secondary
| Measure | Time frame |
|---|---|
| Renal function | on day 7 |
| physician assessed global clinical status | on day 3 and day 7 |
| patient assessed dyspnea | on day 3 and day 7. |
Countries
China
Outcome results
None listed