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

Sponsors

Lead Sponsor: Hebei Medical University

Source Hebei Medical University
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.

Overall Status Completed
Start Date January 2009
Completion Date January 2012
Primary Completion Date September 2011
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Cardiovascular mortality in the 30 days following randomization. 30 days following randomization
Secondary Outcome
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.
Enrollment 102
Condition
Intervention

Intervention Type: Drug

Intervention Name: glucocorticoid

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

Arm Group Label: glucocorticoid

Other Name: Dexamethasone Sodium Phosphate; prednisone acetate tablets

Intervention Type: Drug

Intervention Name: standard care

Description: The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.

Arm Group Label: Standard care

Other Name: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kunshen Liu, MD Principal Investigator The First Hospital of Hebei Medical University
Location
Facility: The First Hospital of Hebei Medical University
Location Countries

China

Verification Date

February 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hebei Medical University

Investigator Full Name: Kun-shen Liu M.D.

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: glucocorticoid

Type: Experimental

Label: Standard care

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov