Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
- Registration Number
- NCT03875183
- Lead Sponsor
- Innolife Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INL1 50mg BID INL1 INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose INL1 300 mg BID INL1 INL1 300mg dose to be given twice daily using three 100mg capsules at each dose Placebo Placebo Placebo dose to be given twice daily using 3 placebo capsules at each dose INL1 150 mg BID INL1 INL1 150mg dose to be given twice daily using three 50mg capsules at each dose
- Primary Outcome Measures
Name Time Method Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) Baseline - 12 weeks Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from Baseline to 12 weeks
- Secondary Outcome Measures
Name Time Method Composite Heart Failure (HF) Improvement Score Baseline - 12 weeks Composite HF Improvement Score, summarizing changes in 4 HF outcomes (NT-proBNP, left ventricular end-systolic volume \[LVESV\], NYHA class, and 6 Minute Walk Test) from Baseline to 12 weeks
Change in Left Ventricular End Diastolic (LVED) Baseline - 12 weeks Echocardiogram finding: change in LVED from Baseline to 12 weeks
Change in ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') Baseline - 12 weeks Echocardiogram finding: change in E/E' ratio from Baseline to 12 weeks
Change in Left Atrial Volume (LAV) Baseline - 12 weeks Echocardiogram finding: change in LAV from Baseline to 12 weeks
Change in Left Ventricular End Systolic (LVES) Baseline - 12 weeks Echocardiogram finding: change in LVES from Baseline to 12 weeks
Change in Left Ventricular End Diastolic Volume (LVEDV) Baseline - 12 weeks Echocardiogram finding: change in LVEDV from Baseline to 12 weeks
Change in Left Ventricular End Systolic Volume (LVESV) Baseline - 12 weeks Echocardiogram finding: change in LVESV from Baseline to 12 weeks
Change in Left Ventricular Systolic Volume (LVSV) Baseline - 12 weeks Echocardiogram finding: change in LVSV from Baseline to 12 weeks
Change in Left Ventricular Ejection Fraction (LVEF) Baseline - 12 weeks Echocardiogram finding: change in LVEF from Baseline to 12 weeks
Change in Left Ventricular Mass (LVM) Baseline - 12 weeks Echocardiogram finding: change in LVM from Baseline to 12 weeks
Change in Left Ventricular End Diastolic Diameter (LVEDD) Baseline - 12 weeks Echocardiogram finding: change in LVEDD from Baseline to 12 weeks
Change in Left Ventricular End Systolic Diameter (LVESD) Baseline - 12 weeks Echocardiogram finding: change in LVESD from Baseline to 12 weeks
Change in Left Ventricular Fractional Shortening (LVFS) Baseline - 12 weeks Echocardiogram finding: change in LVFS from Baseline to 12 weeks
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) Baseline - 12 weeks Echocardiogram finding: change in TAPSE from Baseline to 12 weeks
Change in Tricuspid Regurgitation (TR) peak velocity Baseline - 12 weeks Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks
Change in Tricuspid Regurgitation (TR) gradient Baseline - 12 weeks Echocardiogram finding: change in TR gradient from Baseline to 12 weeks
Change in Tricuspid Regurgitation (TR) severity Baseline - 12 weeks Echocardiogram finding: change in TR severity from Baseline to 12 weeks
Change in Inferior Vena Cava (IVC) Diameter Baseline - 12 weeks Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks
Change in New York Heart Association (NYHA) class Baseline to 12 weeks Change in NYHA class from Baseline to 12 weeks
Change in 6 minute walk distance Baseline to 12 weeks Change in 6 minute walk distance from Baseline to 12 weeks
Quality of Life (QoL) based on Kansas City Cardiomyopathy Questionnaire (KCCQ) change Baseline to 12 weeks QoL based on change in KCCQ from Baseline to 12 weeks. Quality of Life scale can range from 0 to 100, with higher values indicating a better outcome. Change will be calculated by subtraction.
Time to earliest event among the composite of cardiovascular (CV) death, hospitalization for HF, and unplanned use of intravenous diuretics or intensification of oral diuretic dose Baseline to 12 weeks Time to earliest event among the composite of CV death, hospitalization for HF, and unplanned use of intravenous diuretics or intensification of oral diuretic dose from Baseline to 12 weeks
Trial Locations
- Locations (13)
Stern Cardiovascular
🇺🇸Germantown, Tennessee, United States
UCLA School of Medicine
🇺🇸Torrance, California, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Universal Axon Clinical Research
🇺🇸Doral, Florida, United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
🇺🇸Wichita, Kansas, United States
Grady Clinical Research Center
🇺🇸Atlanta, Georgia, United States
Clinical Trials of America LA, LLC
🇺🇸Monroe, Louisiana, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
St Louis Heart and Vascular
🇺🇸Saint Louis, Missouri, United States
East Texas Cardiology
🇺🇸Houston, Texas, United States
Angiocardiac Care of Texas
🇺🇸Houston, Texas, United States
Chongqing University 3 Gorges Hospital
🇨🇳Chongqing, China
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States