Bumetanide Versus Furosemide in Heart Failure
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Furosemide (Drug); Bumetanide (Drug); furosemide (Drug); bumetanide (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s): Neville G Suskin, MBChB, MSc, Principal Investigator, Affiliation: LHSC, University of Western Ontario
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.
Clinical Details
Official title: Bumetanide Has a More Favourable Effect on Insulin Resistance Than Furosemide in Patients With Heart Failure - A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD)
Secondary outcome: Fasting blood glucoseGlycosylated hemoglobin (HbA1c) Serum creatinine, sodium, potassium, and chloride Submaximal exercise capacity as determined by the 6-minute walk test New York Heart Association Function Class heart failure (NYHA FC)
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
University Hospital, London Health Sciences Centre, London, Ontario N6A 5A5, Canada
Additional Information
Starting date: January 2011
Last updated: March 26, 2014
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