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Sponsors and Collaborators: |
Lawson Health Research Institute University of Western Ontario, Canada |
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Information provided by: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00372762 |
Patients with NYHA FC II-III heart failure will be randomized in a cross-over fashion to 8 weeks of bumetanide vs. 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 |
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Heart Failure |
Drug: Furosemide Drug: Bumetanide Drug: furosemide Drug: bumetanide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Bumetanide Has a More Favourable Effect on Insulin Resistance Than Furosemide in Patients With Heart Failure - A Pilot Study |
Estimated Enrollment: | 15 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Arm A patients will take 20mg to 80mg furosemide orally once or twice daily for an 8-week period.
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Drug: Furosemide
Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover
Drug: furosemide
20mg to 80mg orally once or twice daily
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B: Active Comparator
Eight-week bumetanide therapy at an equipotent dose to furosemide therapy (1mg bumetanide is equivalent to 40mg furosemide).
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Drug: Bumetanide
Equivalent dose to pre-existing furosemide will be used
Drug: bumetanide
0.5mg to 2mg orally once or twice daily
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Neville Suskin, MBChB, etc | (519) 685-8300 ext 33488 | neville.suskin@lhsc.on.ca |
Canada, Ontario | |
University Hospital, London Health Sciences Centre | |
London, Ontario, Canada, N6A 5W9 |
Principal Investigator: | Neville Suskin, MBChB, etc | LHSC, University of Western Ontario |
Responsible Party: | Lawson Health Research Institute ( Dr. Neville Suskin ) |
Study ID Numbers: | R-06-415 |
Study First Received: | September 6, 2006 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00372762 |
Health Authority: | Canada: Health Canada |
Insulin resistance heart failure diuretic therapy |
Hyperinsulinism Heart Failure Metabolic Diseases Heart Diseases Bumetanide |
Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Furosemide Insulin |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Diuretics Cardiovascular Diseases Cardiovascular Agents Sodium Potassium Chloride Symporter Inhibitors Pharmacologic Actions |