Clinical trial NCT03875183: Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Heart Failure
Reduced Ejection Fraction
Keywords: Heart failure
Lead sponsor: Innolife Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
timeFrame: Baseline - 12 weeks
Secondary outcomes:
measure: Composite Heart Failure (HF) Improvement Score
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Diastolic (LVED)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Systolic (LVES)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Diastolic Volume (LVEDV)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Systolic Volume (LVESV)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular Systolic Volume (LVSV)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular Mass (LVM)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Diastolic Diameter (LVEDD)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular End Systolic Diameter (LVESD)
timeFrame: Baseline - 12 weeks
measure: Change in Left Ventricular Fractional Shortening (LVFS)
timeFrame: Baseline - 12 weeks
measure: Change in ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')
timeFrame: Baseline - 12 weeks
measure: Change in Left Atrial Volume (LAV)
timeFrame: Baseline - 12 weeks
measure: Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
timeFrame: Baseline - 12 weeks
measure: Change in Tricuspid Regurgitation (TR) peak velocity
timeFrame: Baseline - 12 weeks
measure: Change in Tricuspid Regurgitation (TR) gradient
timeFrame: Baseline - 12 weeks
measure: Change in Tricuspid Regurgitation (TR) severity
timeFrame: Baseline - 12 weeks
measure: Change in Inferior Vena Cava (IVC) Diameter
timeFrame: Baseline - 12 weeks
measure: Change in New York Heart Association (NYHA) class
timeFrame: Baseline to 12 weeks
measure: Change in 6 minute walk distance
timeFrame: Baseline to 12 weeks
measure: Quality of Life (QoL) based on Kansas City Cardiomyopathy Questionnaire (KCCQ) change
timeFrame: Baseline to 12 weeks
measure: 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
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: UCLA School of Medicine
state: California
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Grady Clinical Research Center
state: Georgia
city: Wichita
country: United States
facility: Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
state: Kansas
city: Monroe
country: United States
facility: Clinical Trials of America LA, LLC
state: Louisiana
city: Saint Louis
country: United States
facility: St Louis Heart and Vascular
state: Missouri
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular
state: Tennessee
city: Houston
country: United States
facility: East Texas Cardiology
state: Texas
city: Houston
country: United States
facility: Angiocardiac Care of Texas
state: Texas
city: Chongqing
country: China
facility: Chongqing University 3 Gorges Hospital
Study officials:
affiliation: Innolife Co., Ltd.
name: Michael Chen, MD
role: STUDY_CHAIR
References: