Bumetanide Versus Furosemide in Heart Failure

Last updated: March 26, 2014
Sponsor: Lawson Health Research Institute
Overall Status: Trial Not Available

Phase

3

Condition

Diabetes And Hypertension

Hormone Deficiencies

Chest Pain

Treatment

N/A

Clinical Study ID

NCT00372762
R-06-415
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anticipatedchanges of medications for the duration of the study

  5. No changes to oral anti-diabetic medications (if applicable) for 3 months prior tostudy entry, and no anticipated changes for the duration of the study (metformin,sulphonylurea type, glitazone type)

  6. Ability to provide written consent

Exclusion

Exclusion Criteria:

  1. Known sensitivity to bumetanide

  2. Myocardial infarction, coronary angioplasty, coronary artery bypass surgery, admissionfor 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)

Study Design

Study Start date:
January 01, 2011
Estimated Completion Date:
June 30, 2013

Study 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.

Connect with a study center

  • University Hospital, London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Site Not Available

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