Bumetanide Versus Furosemide in Heart Failure

NCT00372762 | Withdrawn Phase 3

• 1 other identifier: R-06-415
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Insulin resistance; heart failure; diuretic therapy

Outcome Measures

Primary Outcomes (1)

• Insulin resistance, as determined by frequently sampled intravenous glucose tolerance test with minimal model analysis (FSIGT MINMOD)

  3 months

Secondary Outcomes (5)

• Fasting blood glucose

  3 months

• Glycosylated hemoglobin (HbA1c)

  3 months

• Serum creatinine, sodium, potassium, and chloride

  3 months

• Submaximal exercise capacity as determined by the 6-minute walk test

  3 months

• New York Heart Association Function Class heart failure (NYHA FC)

  3 months

Study Arms (2)

Furosemide

ACTIVE COMPARATOR

Patients will be assigned to furosemide therapy (20mg to 80mg) orally, once or twice daily for an 8-week period.

Drug: Furosemide

Bumetanide

ACTIVE COMPARATOR

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

Interventions

furosemide DRUG

Current dose of furosemide will be maintained and equivalent dose bumetanide will be used following crossover

Also known as: Lasix

Furosemide

bumetanide DRUG

Equivalent dose to pre-existing furosemide will be used

Also known as: Bumex, Burinex

Bumetanide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

University Hospital, London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Heart Failure; Insulin Resistance

Interventions

Furosemide; Bumetanide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Neville G Suskin, MBChB, MSc

  LHSC, University of Western Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

CA (1)