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

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: glucocorticoid; Drug: standard care

• Registration Number: NCT00953303
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2011-09
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-19
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
glucocorticoid	glucocorticoid	-
Standard care	standard care	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality in the 30 days following randomization.	30 days following randomization

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China