Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction (TRACER-HF)

Innolife

Status and phase: Unknown; Phase 2

Conditions: Reduced Ejection Fraction; Heart Failure

Treatments: Other: Placebo; Drug: INL1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03875183

2019-000511-89 (EudraCT Number)

INL1-001

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

INL1 50mg BID

Experimental group

Description:

INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose

Treatment:

Drug: INL1

INL1 150 mg BID

Experimental group

Description:

INL1 150mg dose to be given twice daily using three 50mg capsules at each dose

Treatment:

Drug: INL1

INL1 300 mg BID

Experimental group

Description:

INL1 300mg dose to be given twice daily using three 100mg capsules at each dose

Treatment:

Drug: INL1

Placebo

Placebo Comparator group

Description:

Placebo dose to be given twice daily using 3 placebo capsules at each dose

Treatment:

Other: Placebo