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

NCT00953303 | Completed Phase 2 DMC

• 1 other identifier: hebmu 08-12B
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; prednisone; cardiovascular mortality; renal function

Outcome Measures

Primary Outcomes (1)

• Cardiovascular mortality in the 30 days following randomization.

  30 days following randomization

Secondary Outcomes (3)

• 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.

Study Arms (2)

glucocorticoid

EXPERIMENTAL

Drug: glucocorticoid

Standard care

ACTIVE COMPARATOR

Drug: standard care

Interventions

glucocorticoid DRUG

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

glucocorticoid

standard care DRUG

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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Glucocorticoids; dexamethasone 21-phosphate; Prednisone; Standard of Care; Furosemide; Torsemide; Nitroglycerin; Dopamine; Dobutamine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitro Compounds; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenethylamines; Ethylamines

Study Officials

• Kunshen Liu, MD

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 6, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: January 1, 2012
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

CN (1)