Diuretic Efficacy of Dexamethasone in Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00263302
• Other study ID #: 0512-e
• Status: Suspended
• Phase: Phase 1
• First received: December 7, 2005
• Last updated: July 2, 2008
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2005
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.

Description:

Glucocorticoids are known to have pronounced physiological effects in the kidney. Conventional teaching dictates that it should be used with caution in patients with congestive heart failure due to its fluid and sodium retention effects. Surprisingly, despite the widespread prevalence of this belief within the medical community, there are few data to support it. In fact, several small animal studies have documented its striking diuretic effects due to increased renal plasma flow and glomerular filtration rate without changes in the glomerular filtration fraction. We design this study to determine whether glucocorticoids have a potent diuretic effect in patients with heart failure.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Congestive heart failure patients due to any cause

• Patients with normal cortical function

• Congestive heart failure patients who are on diuretic therapy

• Clinically stable and body weight maintained the same for at least 3 days without signs of fluid retention

Exclusion Criteria:

• Patient refusal

• Signs of infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• dexamethasone

Locations

Country	Name	City	State
China	Kunshen Liu	Shijiazhuang	Hebei
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine volume
Primary	urine electrolyte excretion (urine sodium, urine potassium, urine chloride), and urine creatinine.
Primary	serum electrolyte (serum sodium, serum potassium, serum chloride), serum creatinine, serum urea, serum uric Acid.
Primary	fractional sodium excretion
Primary	glomerular filtration rate (calculated by Cockroft and Gault formula).

External Links

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