Heart FailurePhase 3NCT00372762
Bumetanide Versus Furosemide in Heart Failure
A Phase 3 study testing Furosemide and Bumetanide in people with Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Furosemide and Bumetanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jun 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years of age
- NHYA FC II or III HF AND documented LVEF ≤40% within 6 months prior to study entry
- Taking 20 mg to 80 mg furosemide orally once or twice per day
- No changes to cardiac medications for 3 months prior to study entry and no anticipated changes of medications for the duration of the study
- No changes to oral anti-diabetic medications (if applicable) for 3 months prior to study entry, and no anticipated changes for the duration of the study (metformin, sulphonylurea type, glitazone type)
- Ability to provide written consent
Who cannot join
- Known sensitivity to bumetanide
- Myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admission for HF or unstable angina within a 3 month period prior to study recruitment
- Planned coronary intervention within 6 months
- Patients who are taking insulin
- Patients with chronic renal (serum creatinine ≥ 200 μmol/L) or hepatic impairment (known cirrhosis or AST or ALT > 1.5 x upper limit of normal)
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, London Health Sciences Centre
London, Ontario, N6A 5A5
About this study
Official title: Bumetanide Has a More Favourable Effect on Insulin Resistance Than Furosemide in Patients With Heart Failure - A Pilot Study
Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.
Read the detailed description
Insulin resistance is common in patients with heart failure (HF) and is associated with a worse functional capacity and more severe symptoms of heart failure. The majority of HF patients take furosemide on at least a daily basis for symptom relief. Bumetanide is a loop diuretic with a similar therapeutic diuretic effect to furosemide. There is evidence from observational and small comparative trials that bumetanide has a significantly less deleterious effect on indirect measures of insulin resistance compared with furosemide. However, a formal comparison between the 2 drugs using rigorous measures of insulin resistance has never been conducted in patients with HF. If bumetanide can be demonstrated to have a similar diuretic and a superior (less deleterious) effect on insulin resistance in patients with HF, the potential exists for bumetanide to have a significantly reduced morbidity in patients with heart failure compared to furosemide. In order to prepare for such a study, the variance of the MINMOD-derived insulin resistance from the FSIGT (26), in this group of patient needs to be determined along with the feasibility of conducting such a study. Functional capacity will be determined by duplicate 6-minute walk tests.
- Conditions
- Heart Failure
- Being tested
- Furosemide, Bumetanide
- Keywords
- Insulin resistance, heart failure, diuretic therapy
- 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.
FurosemideDrug
Also called Lasix
Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover
BumetanideDrug
Also called Bumex, Burinex
Equivalent dose to pre-existing furosemide will be used
furosemideDrug
Also called Lasix
20mg to 80mg orally once or twice daily
bumetanideDrug
Also called Bumex, Burinex
0.5mg to 2mg orally once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Furosemide | Active comparator | Patients will be assigned to furosemide therapy (20mg to 80mg) orally, once or twice daily for an 8-week period. Receives: Drug: Furosemide |
| Bumetanide | Active comparator | Patients will be assigned to bumetanide therapy at an equipotent dose to furosemide therapy (1mg bumetanide is equivalent to 40mg furosemide)for an 8-week period. Receives: Drug: Bumetanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD)
Measured: 3 months
Secondary outcomes (5)
Fasting blood glucose
Measured: 3 months
Glycosylated hemoglobin (HbA1c)
Measured: 3 months
Serum creatinine, sodium, potassium, and chloride
Measured: 3 months
Submaximal exercise capacity as determined by the 6-minute walk test
Measured: 3 months
New York Heart Association Function Class heart failure (NYHA FC)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startJan 2011
- Primary completionJan 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Due to changes within the research program this study is not feasible at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Principal investigator, Neville Suskin, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Neville G Suskin, MBChB, MSc, Principal investigator, LHSC, University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372762
- Sponsor's protocol ID
- R-06-415
- Status last verified
- Mar 2014
- First submitted
- 6 Sep 2006
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bumetanide Has a More Favourable Effect on Insulin Resistance Than Furosemide in Patients With Heart Failure - A Pilot Study
- ClinicalTrials.gov ID
- NCT00372762
- Acronym / sponsor ID
- R-06-415
- Conditions
- Heart Failure
- Keywords
- Insulin resistance, heart failure, diuretic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to changes within the research program this study is not feasible at this time
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 7 Sep 2006 (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.
Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide versus furosemide therapy (equipotent dose), to test whether bumetanide therapy has a superior effect on insulin resistance compared to furosemide. Patients will be subject to a frequently sampled intravenous glucose tolerance test (FSIGT) with minimal model (MINMOD) analysis to assess insulin resistance and to a 6-minute walk test (6MWT) to assess functional capacity; patient recruitment and retention success, as well as medication adherence, will also be assessed.
Detailed description
Insulin resistance is common in patients with heart failure (HF) and is associated with a worse functional capacity and more severe symptoms of heart failure. The majority of HF patients take furosemide on at least a daily basis for symptom relief. Bumetanide is a loop diuretic with a similar therapeutic diuretic effect to furosemide. There is evidence from observational and small comparative trials that bumetanide has a significantly less deleterious effect on indirect measures of insulin resistance compared with furosemide. However, a formal comparison between the 2 drugs using rigorous measures of insulin resistance has never been conducted in patients with HF. If bumetanide can be demonstrated to have a similar diuretic and a superior (less deleterious) effect on insulin resistance in patients with HF, the potential exists for bumetanide to have a significantly reduced morbidity in patients with heart failure compared to furosemide. In order to prepare for such a study, the variance of the MINMOD-derived insulin resistance from the FSIGT (26), in this group of patient needs to be determined along with the feasibility of conducting such a study. Functional capacity will be determined by duplicate 6-minute walk tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furosemide | Active comparator | Drug: FurosemidePatients will be assigned to furosemide therapy (20mg to 80mg) orally, once or twice daily for an 8-week period. |
| Bumetanide | Active comparator | Drug: BumetanidePatients will be assigned to bumetanide therapy at an equipotent dose to furosemide therapy (1mg bumetanide is equivalent to 40mg furosemide)for an 8-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ≥18 years of age
- NHYA FC II or III HF AND documented LVEF ≤40% within 6 months prior to study entry
- Taking 20 mg to 80 mg furosemide orally once or twice per day
- No changes to cardiac medications for 3 months prior to study entry and no anticipated changes of medications for the duration of the study
- No changes to oral anti-diabetic medications (if applicable) for 3 months prior to study entry, and no anticipated changes for the duration of the study (metformin, sulphonylurea type, glitazone type)
Key exclusion criteria (5 listed)
- Known sensitivity to bumetanide
- Myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admission for HF or unstable angina within a 3 month period prior to study recruitment
- Planned coronary intervention within 6 months
- Patients who are taking insulin
- Patients with chronic renal (serum creatinine ≥ 200 μmol/L) or hepatic impairment (known cirrhosis or AST or ALT > 1.5 x upper limit of normal)
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 |
|---|---|---|
| FurosemideAlso: LasixCurrent dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover | Drug | Furosemide |
| BumetanideAlso: Bumex, BurinexEquivalent dose to pre-existing furosemide will be used | Drug | Bumetanide |
| furosemideAlso: Lasix20mg to 80mg orally once or twice daily | Drug | Furosemide |
| bumetanideAlso: Bumex, Burinex0.5mg to 2mg orally once or twice daily | Drug | Bumetanide |
Primary outcome
Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD)
Time frame: 3 months
5 secondary outcomes
Fasting blood glucose
Time frame: 3 months
Glycosylated hemoglobin (HbA1c)
Time frame: 3 months
Serum creatinine, sodium, potassium, and chloride
Time frame: 3 months
Submaximal exercise capacity as determined by the 6-minute walk test
Time frame: 3 months
New York Heart Association Function Class heart failure (NYHA FC)
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
Neville G Suskin, MBChB, MSc principal investigator
LHSC, University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide and Bumetanide in people with Heart Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 Mar 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD) (time frame: 3 months). 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 27 Mar 2014.