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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: glucocorticoid
* Drug: standard care


Participation Criteria
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Eligibility Criteria
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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: >2-pillow orthopnea before study entry 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucocorticoid<br> | Drug: glucocorticoid<br>* One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.<br>* Other names: Dexamethasone Sodium Phosphate; prednisone acetate tablets;|
| Active Comparator: Standard care<br> | Drug: standard care<br>* The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.<br>* Other names: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality in the 30 days following randomization. |  | 30 days following randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, prednisone, cardiovascular mortality, renal function