Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
NCT ID: NCT03875183
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2020-01-20
2023-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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INL1 50mg BID
INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose
INL1
Capsules
INL1 150 mg BID
INL1 150mg dose to be given twice daily using three 50mg capsules at each dose
INL1
Capsules
INL1 300 mg BID
INL1 300mg dose to be given twice daily using three 100mg capsules at each dose
INL1
Capsules
Placebo
Placebo dose to be given twice daily using 3 placebo capsules at each dose
Placebo
Capsules
Interventions
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INL1
Capsules
Placebo
Capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Innolife Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Chen, MD
Role: STUDY_CHAIR
Innolife Co., Ltd.
Locations
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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
Grady Clinical Research Center
Atlanta, Georgia, United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
Clinical Trials of America LA, LLC
Monroe, Louisiana, United States
St Louis Heart and Vascular
St Louis, Missouri, United States
Clinical Research of Gastonia
Gastonia, North Carolina, United States
Medication Management, LLC
Greensboro, North Carolina, United States
Stern Cardiovascular
Germantown, Tennessee, United States
East Texas Cardiology
Houston, Texas, United States
Angiocardiac Care of Texas
Houston, Texas, United States
Chongqing University 3 Gorges Hospital
Chongqing, , China
Countries
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Central Contacts
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Facility Contacts
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Lirong Qui
Role: primary
Other Identifiers
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2019-000511-89
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INL1-001
Identifier Type: -
Identifier Source: org_study_id
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