Clinical trial NCT00953303: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: heart failure
prednisone
cardiovascular mortality
renal function
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Cardiovascular mortality in the 30 days following randomization.
timeFrame: 30 days following randomization
Secondary outcomes:
measure: Renal function
timeFrame: on day 7
measure: physician assessed global clinical status
timeFrame: on day 3 and day 7
measure: patient assessed dyspnea
timeFrame: on day 3 and day 7.
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Kunshen Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: