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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000511-89 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INL1 50mg BID | Experimental | INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose |
|
| INL1 150 mg BID | Experimental | INL1 150mg dose to be given twice daily using three 50mg capsules at each dose |
|
| INL1 300 mg BID | Experimental | INL1 300mg dose to be given twice daily using three 100mg capsules at each dose |
|
| Placebo | Placebo Comparator | Placebo dose to be given twice daily using 3 placebo capsules at each dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INL1 | Drug | Capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Left Ventricular End Diastolic (LVED) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 862-259-4382 | daniel.qi@vita-spes.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Chen, MD | Innolife Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine | Active, not recruiting | Torrance | California | 90502 | United States | |
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| Placebo |
| Other |
Capsules |
|
Echocardiogram finding: change in LVED from Baseline to 12 weeks |
| Baseline - 12 weeks |
| Change in Left Ventricular End Systolic (LVES) | Echocardiogram finding: change in LVES from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular End Diastolic Volume (LVEDV) | Echocardiogram finding: change in LVEDV from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular End Systolic Volume (LVESV) | Echocardiogram finding: change in LVESV from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular Systolic Volume (LVSV) | Echocardiogram finding: change in LVSV from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular Ejection Fraction (LVEF) | Echocardiogram finding: change in LVEF from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular Mass (LVM) | Echocardiogram finding: change in LVM from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular End Diastolic Diameter (LVEDD) | Echocardiogram finding: change in LVEDD from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular End Systolic Diameter (LVESD) | Echocardiogram finding: change in LVESD from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Left Ventricular Fractional Shortening (LVFS) | Echocardiogram finding: change in LVFS from Baseline to 12 weeks | Baseline - 12 weeks |
| 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 |
| Change in Left Atrial Volume (LAV) | Echocardiogram finding: change in LAV from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | Echocardiogram finding: change in TAPSE from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Tricuspid Regurgitation (TR) peak velocity | Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Tricuspid Regurgitation (TR) gradient | Echocardiogram finding: change in TR gradient from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Tricuspid Regurgitation (TR) severity | Echocardiogram finding: change in TR severity from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in Inferior Vena Cava (IVC) Diameter | Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks | Baseline - 12 weeks |
| Change in New York Heart Association (NYHA) class | Change in NYHA class from Baseline to 12 weeks | Baseline to 12 weeks |
| Change in 6 minute walk distance | Change in 6 minute walk distance from Baseline to 12 weeks | Baseline to 12 weeks |
| 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 |
| 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 |
| Innovative Research of West Florida, Inc. |
| Completed |
| Clearwater |
| Florida |
| 33756 |
| United States |
| Universal Axon Clinical Research | Withdrawn | Doral | Florida | 33166 | United States |
| Grady Clinical Research Center | Completed | Atlanta | Georgia | 30303 | United States |
| Via Christi Research, a division of Via Christi Hospitals Wichita, Inc. | Withdrawn | Wichita | Kansas | 67214 | United States |
| Clinical Trials of America LA, LLC | Withdrawn | Monroe | Louisiana | 71203 | United States |
| St Louis Heart and Vascular | Completed | St Louis | Missouri | 63136 | United States |
| Clinical Research of Gastonia | Completed | Gastonia | North Carolina | 28054 | United States |
| Medication Management, LLC | Withdrawn | Greensboro | North Carolina | 27401 | United States |
| Stern Cardiovascular | Withdrawn | Germantown | Tennessee | 38138 | United States |
| East Texas Cardiology | Completed | Houston | Texas | 77002 | United States |
| Angiocardiac Care of Texas | Completed | Houston | Texas | 77025 | United States |
| Chongqing University 3 Gorges Hospital | Recruiting | Chongqing | China |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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