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

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
glucocorticoid
standard care
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, prednisone, cardiovascular mortality, renal function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glucocorticoid

Standard care

Arm Description

Outcomes

Primary Outcome Measures

Cardiovascular mortality in the 30 days following randomization.

Secondary Outcome Measures

Renal function
physician assessed global clinical status
patient assessed dyspnea

Full Information

First Posted
August 3, 2009
Last Updated
February 19, 2012
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00953303
Brief Title
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure
Official Title
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, prednisone, cardiovascular mortality, renal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
glucocorticoid
Arm Type
Experimental
Arm Title
Standard care
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
glucocorticoid
Other Intervention Name(s)
Dexamethasone Sodium Phosphate; prednisone acetate tablets
Intervention Description
One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.
Intervention Type
Drug
Intervention Name(s)
standard care
Other Intervention Name(s)
Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine
Intervention Description
The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.
Primary Outcome Measure Information:
Title
Cardiovascular mortality in the 30 days following randomization.
Time Frame
30 days following randomization
Secondary Outcome Measure Information:
Title
Renal function
Time Frame
on day 7
Title
physician assessed global clinical status
Time Frame
on day 3 and day 7
Title
patient assessed dyspnea
Time Frame
on day 3 and day 7.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: >2-pillow orthopnea before study entry 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunshen Liu, MD
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050031
Country
China

12. IPD Sharing Statement

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

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