Heart Failure, CongestivePhase 1NCT00263302
Diuretic Efficacy of Dexamethasone in Heart Failure
A Phase 1 study testing dexamethasone in people with Heart Failure, Congestive, run by Hebei Medical University at 2 sites in China.
Trial summary
The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- dexamethasone
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2006to Dec 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient refusal
- Signs of infection
Trial locations and contacts
2 sites in 1 country.
China2 sites
Kunshen Liu
Shijiazhuang, Hebei, 050031
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients
The purpose of this study is to determine whether glucocorticoids have potent diuretic effects in patients with congestive heart failure.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- dexamethasone
- Keywords
- dexamethasone, diuretic, congestive heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2005 (estimated)
- Study startMar 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Kunshen Liu, M.D., Study chair, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263302
- Sponsor's protocol ID
- 0512-e
- Status last verified
- Jan 2005
- First submitted
- 7 Dec 2005
- Last updated
- 4 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diuretic Efficacy of Dexamethasone in Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00263302
- Acronym / sponsor ID
- 0512-e
- Conditions
- Heart Failure, Congestive
- Keywords
- dexamethasone, diuretic, congestive heart failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 60 participants
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Dec 2006
- First posted
- 8 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient refusal
- Signs of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone | Drug | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kunshen Liu, M.D. study chair
Hebei Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dexamethasone in people with Heart Failure, Congestive, run by Hebei Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urine volume. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.