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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This study has been withdrawn prior to enrollment.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:
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Serum creatinine, sodium, potassium, and chloride [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Submaximal exercise capacity as determined by the 6-minute walk test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • New York Heart Association Function Class heart failure (NYHA FC) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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:
  • Bumex
  • Burinex
Drug: bumetanide
0.5mg to 2mg orally once or twice daily
Other Names:
  • Bumex
  • Burinex

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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Canada: Health Canada

Keywords provided by 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 September 26, 2016