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CompletedNCT00953303Updated Feb 22, 2012

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

A Phase 2/3 interventional study of glucocorticoid and standard care in Heart Failure, sponsored by Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Hebei Medical University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • heart failure
  • prednisone
  • cardiovascular mortality
  • renal function
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 102 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hebei Medical University is the lead sponsor of 39 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    glucocorticoid

    Drug: glucocorticoid

  • Active comparator
    Standard care

    Drug: standard care

Interventions

  • Drugglucocorticoid

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

    Also known as: Dexamethasone Sodium Phosphate; prednisone acetate tablets

  • Drugstandard care

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

    Also known as: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

06

What researchers measure

Primary outcomes

  1. Cardiovascular mortality in the 30 days following randomization.

    Time frame: 30 days following randomization

Secondary outcomes

  1. Renal function

    Time frame: on day 7

  2. physician assessed global clinical status

    Time frame: on day 3 and day 7

  3. patient assessed dyspnea

    Time frame: on day 3 and day 7.

07

Study locations

1 site
  • The First Hospital of Hebei Medical University
    Shijiazhuang, Hebei 050031, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00953303
Lead sponsor
Hebei Medical University
Responsible party
Kun-shen Liu M.D. (Professor, Hebei Medical University) — Principal investigator
First posted
Aug 6, 2009
Start date
Jan 2009
Primary completion
Sep 2011
Completion
Jan 2012
Last update
Feb 22, 2012

Study contacts

Kunshen Liu, MD
principal investigator · The First Hospital of Hebei Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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