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OpenTrials
Completed

NCT Number: NCT00953303

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucocorticoid

Drug

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

Other names: Dexamethasone Sodium Phosphate; prednisone acetate tablets

Standard care

Drug

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

Other names: Furosemide; torsemide; nitroglycerin; dopamine; Dobutamine

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.

Sponsors and collaborators

Lead sponsor

Hebei Medical University

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Aug 6, 2009
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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