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

NCT ID: NCT00953303

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

glucocorticoid

Group Type: EXPERIMENTAL

glucocorticoid

Intervention Type: DRUG

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

Standard care

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: DRUG

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

Interventions

glucocorticoid

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

Intervention Type: DRUG

standard care

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

Intervention Type: DRUG

Other Intervention Names

Dexamethasone Sodium Phosphate; prednisone acetate tablets; 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kun-shen Liu M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kunshen Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

hebmu 08-12B

Identifier Type: -

Identifier Source: org_study_id