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Bumetanide Versus Furosemide in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372762
Recruitment Status : Withdrawn (Due to changes within the research program this study is not feasible at this time)
First Posted : September 7, 2006
Last Update Posted : March 27, 2014
University of Western Ontario, Canada
Information provided by (Responsible Party):
Neville Suskin, Lawson Health Research Institute

Brief 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. 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 or disease Intervention/treatment Phase
Heart Failure Drug: Furosemide Drug: Bumetanide Drug: furosemide Drug: bumetanide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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:
  • Bumex
  • Burinex

Drug: bumetanide
0.5mg to 2mg orally once or twice daily
Other Names:
  • Bumex
  • Burinex

Primary Outcome Measures :
  1. Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Fasting blood glucose [ Time Frame: 3 months ]
  2. Glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months ]
  3. Serum creatinine, sodium, potassium, and chloride [ Time Frame: 3 months ]
  4. Submaximal exercise capacity as determined by the 6-minute walk test [ Time Frame: 3 months ]
  5. New York Heart Association Function Class heart failure (NYHA FC) [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and women ≥18 years of age
  2. NHYA FC II or III HF AND documented LVEF ≤40% within 6 months prior to study entry
  3. Taking 20 mg to 80 mg furosemide orally once or twice per day
  4. No changes to cardiac medications for 3 months prior to study entry and no anticipated changes of medications for the duration of the study
  5. 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)
  6. Ability to provide written consent

Exclusion Criteria:

  1. Known sensitivity to bumetanide
  2. Myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admission for HF or unstable angina within a 3 month period prior to study recruitment
  3. Planned coronary intervention within 6 months
  4. Patients who are taking insulin
  5. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372762

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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
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Principal Investigator: Neville G Suskin, MBChB, MSc LHSC, University of Western Ontario
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Responsible Party: Neville Suskin, Principal Investigator, Lawson Health Research Institute Identifier: NCT00372762    
Other Study ID Numbers: R-06-415
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014
Keywords provided by Neville Suskin, Lawson Health Research Institute:
Insulin resistance
heart failure
diuretic therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action