Heart Failure Clinical Trial
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of HF requiring chronic treatment of loop diuretics
Left Ventricular Ejection Fraction (LVEF) ≤ 40% at screening by echocardiography
N-Terminal-prohormone of Brain Natriuretic Peptide (NT-proBNP) ≥400 pg/mL at screening for patients without atrial fibrillation or atrial flutter, or, NT-proBNP ≥ 1,200 pg/mL at screening for patients with atrial fibrillation or atrial flutter
Treated for Heart Failure with stable, optimal pharmacological therapy
Acceptable screening echocardiographic image quality
Exclusion Criteria:
Female patients of childbearing potential
Patients with a New York Heart Association (NYHA) Class I or IV
Heart failure that is clearly caused by toxin / drug such as Adriamycin
Significant medical conditions or recent history suggesting the patient's study participation will potentially pose a major risk to patient's safety and well-being
Need for routine scheduled outpatient IV infusions for Heart Failure or scheduled ultrafiltration
History of rhabdomyolysis or history of autoimmune diseases
Severe renal disease
Hepatic disease
Pulmonary disease limiting exercise capacity
Atrial fibrillation with rapid ventricular response
Life expectancy of less than 6 months
Type 1 diabetes mellitus or Type 2 diabetes mellitus with very poor glycemic control
Patients with anemia
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There are 12 Locations for this study
Torrance California, 90502, United States
Clearwater Florida, 33756, United States
Doral Florida, 33166, United States
Atlanta Georgia, 30303, United States
Wichita Kansas, 67214, United States
Monroe Louisiana, 71203, United States
Saint Louis Missouri, 63136, United States
Gastonia North Carolina, 28054, United States
Greensboro North Carolina, 27401, United States
Germantown Tennessee, 38138, United States
Houston Texas, 77002, United States
Houston Texas, 77025, United States
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