Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Reduced Ejection Fraction,Heart Failure
Age (in years)
18 - 75
Phase
Phase 2
Participants needed
200
Est. Completion Date
Jan 31, 2023
Treatment type
Interventional
Sponsor
Innolife Co., Ltd.
ClinicalTrials.gov identifier
NCT03875183
Study number
INL1-001
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