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

Sponsor

Hebei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT00953303

Collaborator

(none)

102

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: glucocorticoid Drug: standard care	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: glucocorticoid	Drug: glucocorticoid One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day. Other Names: Dexamethasone Sodium Phosphate; prednisone acetate tablets
Active Comparator: Standard care	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 Names: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

Arm

Intervention/Treatment

Experimental: glucocorticoid

Drug: glucocorticoid

One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.

Other Names:

Dexamethasone Sodium Phosphate; prednisone acetate tablets

Active Comparator: Standard care

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 Names:

Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

Outcome Measures

Primary Outcome Measures

Cardiovascular mortality in the 30 days following randomization. [30 days following randomization]

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.