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

H

Hebei Medical University

Status and phase

Completed
Phase 3
Phase 2

Conditions

Heart Failure

Treatments

Drug: standard care
Drug: glucocorticoid

Study type

Interventional

Funder types

Other

Identifiers

NCT00953303
hebmu 08-12B

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No 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:

    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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

glucocorticoid
Experimental group
Treatment:
Drug: glucocorticoid
Standard care
Active Comparator group
Treatment:
Drug: standard care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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