Chronic Stable Heart FailurePhase 4NCT00664222
Spironolactone and Insulin Resistance in Chronic Heart Failure (CHF)
A Phase 4 study testing spironolactone + furosemide in people with Chronic Stable Heart Failure, run by Tottori University Hospital.
Trial summary
The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Stable Heart Failure
- What is being tested?
- spironolactone + furosemide
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2005
- Phase
- Phase 4
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- chronic stable heart failure
Who cannot join
- renal dysfunction or under treatment with antidiabetic agents
About this study
Official title: Effects of Spironolactone on Insulin Resistance in Patients With Chronic Heart Failure
The purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.
Read the detailed description
Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.
- Conditions
- Chronic Stable Heart Failure
- Being tested
- spironolactone + furosemide
- Keywords
- heart failure, insulin resistance, inflammatory cytokine, spironolactone, furosemide
- Medical subject headings
- Heart Failure, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactone + furosemideDrug
spironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startJan 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable Heart FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tottori University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664222
- Sponsor's protocol ID
- #344.1
- Status last verified
- Apr 2008
- First submitted
- 18 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Spironolactone on Insulin Resistance in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00664222
- Acronym / sponsor ID
- #344.1
- Conditions
- Chronic Stable Heart Failure
- Keywords
- heart failure, insulin resistance, inflammatory cytokine, spironolactone, furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tottori University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Dec 2005
- First posted
- 22 Apr 2008 (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 evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.
Detailed description
Diuretics is useful in CHF patients. On the other hand, they deteriorate glucose metabolism. Therefore, the purpose of this study is to evaluate the effects of spironolactone and furosemide on insulin resistance in patients with chronic heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- chronic stable heart failure
Key exclusion criteria (1 listed)
- renal dysfunction or under treatment with antidiabetic agents
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 |
|---|---|---|
| spironolactone + furosemidespironolactone 25mg/day, 16 weeks and furosemide 20mg/day, 16weeks | Drug | – |
Primary outcome
insulin resistance
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spironolactone + furosemide in people with Chronic Stable Heart Failure, run by Tottori University Hospital.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
insulin resistance (time frame: 16 weeks). 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 22 Apr 2008.