Diuretic Efficacy of Dexamethasone in Heart Failure | NCT00263302

Studies
Diuretic Efficacy of Dexamethasone in Heart Failure

NCT00263302

Sponsor

Hebei Medical University

Status

Suspended

Last Update Posted

Jul 4, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Heart Failure, Congestive

Interventions

dexamethasone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2005

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Dec 7, 2005

First Submission Date that Met QC Criteria

Dec 7, 2005

First Posted Date

Dec 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2008

Last Update Posted Date

Jul 4, 2008Estimated

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kunshen Liu, M.D.	Hebei Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kunshen Liu		Shijiazhuang	Hebei	050031	China
The First Hospital of Hebei Medical University

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided