Bumetanide Versus Furosemide in Heart Failure

• Status: Withdrawn
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lawson Health Research Institute
• Collaborator: University of Western Ontario, Canada
• Treatments: Bumetanide; Furosemide

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)