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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03875183
Other study ID # INL1-001
Secondary ID 2019-000511-89
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 20, 2020
Est. completion date January 2023

Study information

Verified date March 2022
Source Innolife Co., Ltd.
Contact Study Director
Phone 862-259-4382
Email daniel.qi@vita-spes.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INL1
Capsules
Other:
Placebo
Capsules

Locations

Country Name City State
China Chongqing University 3 Gorges Hospital Chongqing
United States Grady Clinical Research Center Atlanta Georgia
United States Innovative Research of West Florida, Inc. Clearwater Florida
United States Universal Axon Clinical Research Doral Florida
United States Clinical Research of Gastonia Gastonia North Carolina
United States Stern Cardiovascular Germantown Tennessee
United States Medication Management, LLC Greensboro North Carolina
United States Angiocardiac Care of Texas Houston Texas
United States East Texas Cardiology Houston Texas
United States Clinical Trials of America LA, LLC Monroe Louisiana
United States St Louis Heart and Vascular Saint Louis Missouri
United States UCLA School of Medicine Torrance California
United States Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Innolife Co., Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from Baseline to 12 weeks Baseline - 12 weeks
Secondary Composite Heart Failure (HF) Improvement Score 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 Baseline - 12 weeks
Secondary Change in Left Ventricular End Diastolic (LVED) Echocardiogram finding: change in LVED from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular End Systolic (LVES) Echocardiogram finding: change in LVES from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular End Diastolic Volume (LVEDV) Echocardiogram finding: change in LVEDV from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular End Systolic Volume (LVESV) Echocardiogram finding: change in LVESV from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular Systolic Volume (LVSV) Echocardiogram finding: change in LVSV from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular Ejection Fraction (LVEF) Echocardiogram finding: change in LVEF from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular Mass (LVM) Echocardiogram finding: change in LVM from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular End Diastolic Diameter (LVEDD) Echocardiogram finding: change in LVEDD from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular End Systolic Diameter (LVESD) Echocardiogram finding: change in LVESD from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Ventricular Fractional Shortening (LVFS) Echocardiogram finding: change in LVFS from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') Echocardiogram finding: change in E/E' ratio from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Left Atrial Volume (LAV) Echocardiogram finding: change in LAV from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) Echocardiogram finding: change in TAPSE from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Tricuspid Regurgitation (TR) peak velocity Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Tricuspid Regurgitation (TR) gradient Echocardiogram finding: change in TR gradient from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Tricuspid Regurgitation (TR) severity Echocardiogram finding: change in TR severity from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in Inferior Vena Cava (IVC) Diameter Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks Baseline - 12 weeks
Secondary Change in New York Heart Association (NYHA) class Change in NYHA class from Baseline to 12 weeks Baseline to 12 weeks
Secondary Change in 6 minute walk distance Change in 6 minute walk distance from Baseline to 12 weeks Baseline to 12 weeks
Secondary Quality of Life (QoL) based on Kansas City Cardiomyopathy Questionnaire (KCCQ) change 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. Baseline to 12 weeks
Secondary 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 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 Baseline to 12 weeks
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