Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

Heart Failure Clinical Trial

— TRACER-HF  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03875183
• Other study ID #: INL1-001
• Secondary ID: 2019-000511-89
• Status: Recruiting
• Phase: Phase 2
• Start date: January 20, 2020
• Est. completion date: January 2023

Study information

• Verified date: March 2022
• Source: Innolife Co., Ltd.
• Contact: Study Director
• Phone: 862-259-4382
• Email: daniel.qi[@]vita-spes.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Reduced Ejection Fraction

Intervention

Drug:
• INL1
Capsules

Other:
• Placebo
Capsules

Locations

Country	Name	City	State
China	Chongqing University 3 Gorges Hospital	Chongqing
United States	Grady Clinical Research Center	Atlanta	Georgia
United States	Innovative Research of West Florida, Inc.	Clearwater	Florida
United States	Universal Axon Clinical Research	Doral	Florida
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Stern Cardiovascular	Germantown	Tennessee
United States	Medication Management, LLC	Greensboro	North Carolina
United States	Angiocardiac Care of Texas	Houston	Texas
United States	East Texas Cardiology	Houston	Texas
United States	Clinical Trials of America LA, LLC	Monroe	Louisiana
United States	St Louis Heart and Vascular	Saint Louis	Missouri
United States	UCLA School of Medicine	Torrance	California
United States	Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Innolife Co., Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in Left Ventricular End Diastolic (LVED)	Echocardiogram finding: change in LVED from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular End Systolic (LVES)	Echocardiogram finding: change in LVES from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular End Diastolic Volume (LVEDV)	Echocardiogram finding: change in LVEDV from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular End Systolic Volume (LVESV)	Echocardiogram finding: change in LVESV from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular Systolic Volume (LVSV)	Echocardiogram finding: change in LVSV from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular Ejection Fraction (LVEF)	Echocardiogram finding: change in LVEF from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular Mass (LVM)	Echocardiogram finding: change in LVM from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular End Diastolic Diameter (LVEDD)	Echocardiogram finding: change in LVEDD from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular End Systolic Diameter (LVESD)	Echocardiogram finding: change in LVESD from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Left Ventricular Fractional Shortening (LVFS)	Echocardiogram finding: change in LVFS from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	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
Secondary	Change in Left Atrial Volume (LAV)	Echocardiogram finding: change in LAV from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)	Echocardiogram finding: change in TAPSE from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Tricuspid Regurgitation (TR) peak velocity	Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Tricuspid Regurgitation (TR) gradient	Echocardiogram finding: change in TR gradient from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Tricuspid Regurgitation (TR) severity	Echocardiogram finding: change in TR severity from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in Inferior Vena Cava (IVC) Diameter	Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks	Baseline - 12 weeks
Secondary	Change in New York Heart Association (NYHA) class	Change in NYHA class from Baseline to 12 weeks	Baseline to 12 weeks
Secondary	Change in 6 minute walk distance	Change in 6 minute walk distance from Baseline to 12 weeks	Baseline to 12 weeks
Secondary	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
Secondary	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