Status:
UNKNOWN
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Lead Sponsor:
Innolife Co., Ltd.
Conditions:
Heart Failure
Reduced Ejection Fraction
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 eva...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03875183
Start Date
January 20 2020
End Date
January 1 2023
Last Update
March 31 2022
Active Locations (13)
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1
UCLA School of Medicine
Torrance, California, United States, 90502
2
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States, 33756
3
Universal Axon Clinical Research
Doral, Florida, United States, 33166
4
Grady Clinical Research Center
Atlanta, Georgia, United States, 30303