Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diuretic Efficacy of Dexamethasone in Heart Failure

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Hebei Medical University
ClinicalTrials.gov Identifier:
NCT00263302
First received: December 7, 2005
Last updated: July 2, 2008
Last verified: January 2005
  Purpose

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


Condition Intervention Phase
Heart Failure, Congestive
Drug: dexamethasone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Hebei Medical University:

Primary Outcome Measures:
  • urine volume
  • urine electrolyte excretion (urine sodium, urine potassium, urine chloride), and urine creatinine.
  • serum electrolyte (serum sodium, serum potassium, serum chloride), serum creatinine, serum urea, serum uric Acid.
  • fractional sodium excretion
  • glomerular filtration rate (calculated by Cockroft and Gault formula).

Estimated Enrollment: 60
Study Start Date: March 2006
Estimated Study Completion Date: December 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00263302

Locations
China, Hebei
Kunshen Liu
Shijiazhuang, Hebei, China, 050031
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050031
Sponsors and Collaborators
Hebei Medical University
Investigators
Study Chair: Kunshen Liu, M.D. Hebei Medical University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00263302     History of Changes
Other Study ID Numbers: 0512-e
Study First Received: December 7, 2005
Last Updated: July 2, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Hebei Medical University:
dexamethasone, diuretic, congestive heart failure

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

ClinicalTrials.gov processed this record on November 25, 2014