Phase 2 Completed N=32 Treatment

The Effects of Decreasing the Lasix Dose on the Cardiorenal System

Heart Failure · Kidney Dysfunction

Source: ClinicalTrials.gov NCT00982423 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Jul 2015

Primary outcomePrimary: Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose — 77; 42; 73; 50 ml/min — p=<0.05

Summary

The investigators' objective is to define the effects of decreasing the furosemide dose on heart, kidney and humoral function in people with compensated heart failure and kidney dysfunction and also in people with compensated heart failure without kidney dysfunction. Secondly, to define the humoral activation in both groups.

Outcome Measures

Outcome	Result	p-value
PRIMARY Renal Function as Measured by Glomerular Filtration Rate (GFR) at Baseline and in Response to Decreasing Furosemide Dose	77; 42; 73; 50	<0.05 sig
SECONDARY Renal Plasma Flow at Baseline and in Response to Decreasing Furosemide Dose	304; 198; 293; 214	—
SECONDARY Aldosterone at Baseline and in Response to Decreasing Furosemide Dose	7.9; 4.9; 7.6; 4.9	—
SECONDARY Plasma Renin Activity at Baseline and in Response to Decreasing Furosemide Dose	4.3; 2.1; 2.7; 1.4	—
SECONDARY Angiotensin II at Baseline and in Response to Decreasing Furosemide Dose	3.3; 3.1; 3.4; 3.2	—
SECONDARY Plasma Cyclic Guanosine Monophosphate (cGMP) at Baseline and in Response to Decreasing Furosemide Dose	5.0; 5.7; 4.6; 7.0	0.075

Eligibility Criteria

Inclusion Criteria for Subjects with Compensated CHF without Renal Dysfunction:

Left ventricular ejection fraction of equal or less than 40% 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 as defined by: a) no change in NYHA symptoms over the past 3 months; b) on stable doses of ACE inhibitor or beta blocker or digoxin or furosemide or angiotensin II receptor, type 1 (AT1) blocker over the past 3 months; c) 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 and a confirmatory calculated creatinine clearance equal or less than 80 ml/min at the time of enrollment.

Inclusion Criteria for Subjects with 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 as defined by: a) no change in NYHA symptoms over the past 3 months; b) on stable doses of ACE inhibitor or beta blocker or digoxin or furosemide or AT1 blocker over the past 3 months; c) 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 assessed within the past 36 months and a confirmatory calculated creatinine clearance equal or less than 60 ml/min and greater than 20 ml/min at the time of enrollment.

Exclusion Criteria for both groups:

Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50%
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Patients who are taking aldosterone antagonist
Hospitalization for decompensated CHF during the past 6 months
Subjects 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, or 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 150 mEq/dL
Serum potassium of 5.5 mEq/dL
Serum digoxin level of > 2.0 ng/ml
Hemoglobin < 10 gm/dl
Other acute or chronic medical conditions 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
Patients with an allergy to iodine.
Female subject who is pregnant or breastfeeding
In the opinion of the investigator is unlikely to comply with the study protocol or is unsuitable for any reason.

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Data sourced from ClinicalTrials.gov (NCT00982423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.