A Study of the Effects of Decreasing the Lasix Dose on the Cardiorenal System

Overview

About this study

The purpose of this study is to define the effects of decreasing the furosemide (lasix) dose on heart, kidney and biochemical balance, in people with compensated heart failure and kidney dysfunction and also in people with compensated heart failure without kidney dysfunction.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Compensated CHF without Renal Dysfunction
    • Left ventricular ejection fraction equal or less than 40% as assessed by echocardiography, nuclear scan, MRI, or left ventriculogram within the past 36 months
    • Stable New York Heart Association (NYHA) class II and III symptoms defined by
      • No change in NYHA symptoms over the past 3 months
      • On stable doses of an ACE inhibitor, beta blocker, digoxin, furosemide, or angiotensin II receptor type 1 blocker over the past 3 months
      • No episode of decompensated CHF over the past 6 months
    • Calculated creatinine clearance of equal or less than 80 ml/min, using the Cockcroft-Gault formula assessed within the past 36 months
      • Confirmatory calculated creatinine clearance equal or less than 80 ml/min at the time of enrollment
  • Compensated CHF with Renal Dysfunction
    • Left ventricular ejection fraction of equal or less than 40 assessed by echocardiography, nuclear scan or left ventriculogram within the past 36 months
    • Stable New York Heart Association (NYHA) class II and III symptoms defined by
      • No change in NYHA symptoms over the past 3 months
      • On stable doses of an ACE inhibitor, beta blocker, digoxin, furosemide, or AT1 blocker over the past 3 months
      • No episode of decompensated CHF over the past 6 months
    • Calculated creatinine clearance of equal or less than 60 ml/min and greater than 20 ml/min, using the Cockcroft-Gault formula and assessed within the past 36 months
      • Confirmatory calculated creatinine clearance equal or less than 60 ml/min and greater than 20 ml/min at the time of enrollment

Exclusion Criteria

  • Prior diagnosis of intrinsic renal disease including renal artery stenosis of > 50%
  • Peritoneal or hemodialysis within 90 days 
  • Anticipation that dialysis or ultrafiltration of any form will be required during the study period
  • Taking aldosterone antagonist
  • Hospitalization for decompensated CHF during the past 6 months
  • On other diuretics besides furosemide
  • Myocardial infarction within 6 months of screening
  • Unstable angina within 6 months of screening or any evidence of myocardial ischemia
  • Significant valvular stenosis
  • Hypertrophic, restrictive or obstructive cardiomyopathy
  • Constrictive pericarditis
  • Primary pulmonary hypertension
  • Biopsy proven active myocarditis
  • Severe congenital heart diseases
  • Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
  • Second or third degree heart block without a permanent cardiac pacemaker
  • Stroke within 3 months of screening or other evidence of significantly compromised central nervous system (CNS) perfusion
  • Alanine Aminotransferase (ALT) result >1.5 times the upper limit of normal
  • Serum sodium of < 125 milliequivalent (mEq)/dL or > 150 mEq/dL
  • Serum potassium of < 3.5 mEq/dL or > 5.5 mEq/dL
  • Serum digoxin level of > 2.0 ng/ml
  • Hemoglobin < 10 gm/dl
  • Other acute or chronic medical condition or laboratory abnormality which may increase the risks associated with study participation, or may interfere with interpretation of the data
  • Received an investigational drug within 1 month prior to dosing
  • Has an allergy to iodine
  • Pregnant or breastfeeding
  • In the opinion of the investigator is unlikely to comply with the study protocol, or is unsuitable for any reason

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Horng Chen, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20314926

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