NCT00263302

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 4, 2008

Status Verified

January 1, 2005

First QC Date

December 7, 2005

Last Update Submit

July 2, 2008

Conditions

Heart Failure, Congestive

Keywords

dexamethasone, diuretic, congestive heart failure

Outcome Measures

Primary Outcomes (5)

  • 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).

Interventions

dexamethasoneDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient refusal
  • Signs of infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kunshen Liu

Shijiazhuang, Hebei, 050031, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Kunshen Liu, M.D.

    Hebei Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2005

First Posted

December 8, 2005

Study Start

March 1, 2006

Study Completion

December 1, 2006

Last Updated

July 4, 2008

Record last verified: 2005-01

Locations

CN(2)