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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kun-shen Liu M.D., Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00953303
First received: August 3, 2009
Last updated: February 19, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: glucocorticoid
Drug: standard care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure

Resource links provided by NLM:


Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • Cardiovascular mortality in the 30 days following randomization. [ Time Frame: 30 days following randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: on day 7 ] [ Designated as safety issue: Yes ]
  • physician assessed global clinical status [ Time Frame: on day 3 and day 7 ] [ Designated as safety issue: No ]
  • patient assessed dyspnea [ Time Frame: on day 3 and day 7. ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glucocorticoid Drug: glucocorticoid
One dose of Dexamethasone (20mg/day) followed by prednisone 1mg/kg/day with a maximum dose of 60mg/day.
Other Name: Dexamethasone Sodium Phosphate; prednisone acetate tablets
Active Comparator: Standard care Drug: standard care
The patients will be given standard care such as diuretics, inotropic and/or vasodilator in acute decompensated congestive heart failure management.
Other Name: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953303

Locations
China, Hebei
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
Investigators
Principal Investigator: Kunshen Liu, MD Hebei Medical University First Hospital
  More Information

No publications provided

Responsible Party: Kun-shen Liu M.D., Professor, Hebei Medical University
ClinicalTrials.gov Identifier: NCT00953303     History of Changes
Other Study ID Numbers: hebmu 08-12B
Study First Received: August 3, 2009
Last Updated: February 19, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hebei Medical University:
heart failure
prednisone
cardiovascular mortality
renal function

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Glucocorticoids
Prednisone
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014