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Bumetanide Versus Furosemide in Heart Failure
This study has been withdrawn prior to enrollment.
(Due to changes within the research program this study is not feasible at this time)
Sponsor:
Lawson Health Research Institute
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Neville Suskin, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00372762
First received: September 6, 2006
Last updated: March 26, 2014
Last verified: March 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Heart Failure | Drug: Furosemide Drug: Bumetanide Drug: furosemide Drug: bumetanide | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Bumetanide Has a More Favourable Effect on Insulin Resistance Than Furosemide in Patients With Heart Failure - A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Neville Suskin, Lawson Health Research Institute:
Primary Outcome Measures:
- Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD) [ Time Frame: 3 months ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 0 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Furosemide
Patients will be assigned to furosemide therapy (20mg to 80mg) orally, once or twice daily for an 8-week period.
|
Drug: Furosemide
Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover
Other Name: Lasix
Drug: furosemide
20mg to 80mg orally once or twice daily
Other Name: Lasix
|
|
Active Comparator: Bumetanide
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.
|
Drug: Bumetanide
Equivalent dose to pre-existing furosemide will be used
Other Names:
Drug: bumetanide
0.5mg to 2mg orally once or twice daily
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00372762
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372762
Locations
| Canada, Ontario | |
| University Hospital, London Health Sciences Centre | |
| London, Ontario, Canada, N6A 5A5 | |
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
| Principal Investigator: | Neville G Suskin, MBChB, MSc | LHSC, University of Western Ontario |
More Information
| Responsible Party: | Neville Suskin, Principal Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT00372762 History of Changes |
| Other Study ID Numbers: |
R-06-415 |
| Study First Received: | September 6, 2006 |
| Last Updated: | March 26, 2014 |
Keywords provided by Neville Suskin, Lawson Health Research Institute:
|
Insulin resistance heart failure diuretic therapy |
Additional relevant MeSH terms:
|
Heart Failure Insulin Resistance Heart Diseases Cardiovascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Furosemide |
Bumetanide Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 18, 2017