Congestive Heart FailureNCT00860340
Hemodynamic Effects of Spironolactone in Patients With Heart Failure
A study testing Spironolactone in people with Congestive Heart Failure, run by University of Toledo Health Science Campus at 1 site in United States.
Trial summary
To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action. Randomized, two group placebo controlled, single blind study. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Oct 2006
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CHF
- 21 - 80 years
- Serum creatinine < 2 mg/dL
- Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks
Who cannot join
- Less than 21 years
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action.
Randomized, two group placebo controlled, single blind study.
- Conditions
- Congestive Heart Failure
- Being tested
- Spironolactone
- Keywords
- Congestive Heart Failure, Hemodynamics, Echocardiographs
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Study patient will take 100mg tablet of Spironolactone Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiogram
Measured: 3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
Measure of Kidney function and potassium levels
Measured: This will be taken before drug, two hours after and the following day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startFeb 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo Health Science Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860340
- Sponsor's protocol ID
- xMUO-02
- Status last verified
- Dec 2014
- First submitted
- 11 Mar 2009
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Spironolactone in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00860340
- Acronym / sponsor ID
- xMUO-02
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Hemodynamics, Echocardiographs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Toledo Health Science CampusUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 12 Mar 2009 (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.
To determine if the beneficial effect of spironolactone in patients with congestive heart failure is in part due to its intrinsic inotropic action.
Randomized, two group placebo controlled, single blind study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SpironolactoneStudy patient will take 100mg tablet of Spironolactone |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CHF
- 21 - 80 years
- Serum creatinine < 2 mg/dL
- Serum potassium 2.7 - 4.5 mg/dL measured within past 4 weeks
Key exclusion criteria (2 listed)
- Less than 21 years
- Pregnancy
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 |
|---|---|---|
| Spironolactone100 mg tablet of Spironolactone (Aldactone) by mouth with half a glass of water. | Drug | 1 |
Primary outcome
Echocardiogram
Time frame: 3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug
Measure of Kidney function and potassium levels
Time frame: This will be taken before drug, two hours after and the following day
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 10 Dec 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spironolactone in people with Congestive Heart Failure, run by University of Toledo Health Science Campus at 1 site in United States.
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: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Echocardiogram (time frame: 3 measurements 15 minutes apart before drug and 15 minutes for 2 hours after drug). The study lists 2 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 10 Dec 2014.