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

Primary Purpose

Heart Failure, Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
INL1
Placebo
Sponsored by
Innolife Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UCLA School of Medicine
  • Innovative Research of West Florida, Inc.
  • Universal Axon Clinical Research
  • Grady Clinical Research Center
  • Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
  • Clinical Trials of America LA, LLC
  • St Louis Heart and Vascular
  • Clinical Research of Gastonia
  • Medication Management, LLC
  • Stern Cardiovascular
  • East Texas Cardiology
  • Angiocardiac Care of Texas
  • Chongqing University 3 Gorges HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

INL1 50mg BID

INL1 150 mg BID

INL1 300 mg BID

Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2019
Last Updated
March 28, 2022
Sponsor
Innolife Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03875183
Brief Title
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innolife Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Reduced Ejection Fraction
Keywords
Heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INL1 50mg BID
Arm Type
Experimental
Arm Description
INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose
Arm Title
INL1 150 mg BID
Arm Type
Experimental
Arm Description
INL1 150mg dose to be given twice daily using three 50mg capsules at each dose
Arm Title
INL1 300 mg BID
Arm Type
Experimental
Arm Description
INL1 300mg dose to be given twice daily using three 100mg capsules at each dose
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose to be given twice daily using 3 placebo capsules at each dose
Intervention Type
Drug
Intervention Name(s)
INL1
Intervention Description
Capsules
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Capsules
Primary Outcome Measure Information:
Title
Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Description
Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Secondary Outcome Measure Information:
Title
Composite Heart Failure (HF) Improvement Score
Description
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
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Diastolic (LVED)
Description
Echocardiogram finding: change in LVED from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Systolic (LVES)
Description
Echocardiogram finding: change in LVES from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Diastolic Volume (LVEDV)
Description
Echocardiogram finding: change in LVEDV from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Systolic Volume (LVESV)
Description
Echocardiogram finding: change in LVESV from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular Systolic Volume (LVSV)
Description
Echocardiogram finding: change in LVSV from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular Ejection Fraction (LVEF)
Description
Echocardiogram finding: change in LVEF from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular Mass (LVM)
Description
Echocardiogram finding: change in LVM from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Diastolic Diameter (LVEDD)
Description
Echocardiogram finding: change in LVEDD from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular End Systolic Diameter (LVESD)
Description
Echocardiogram finding: change in LVESD from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Ventricular Fractional Shortening (LVFS)
Description
Echocardiogram finding: change in LVFS from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')
Description
Echocardiogram finding: change in E/E' ratio from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Left Atrial Volume (LAV)
Description
Echocardiogram finding: change in LAV from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Description
Echocardiogram finding: change in TAPSE from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Tricuspid Regurgitation (TR) peak velocity
Description
Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Tricuspid Regurgitation (TR) gradient
Description
Echocardiogram finding: change in TR gradient from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Tricuspid Regurgitation (TR) severity
Description
Echocardiogram finding: change in TR severity from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in Inferior Vena Cava (IVC) Diameter
Description
Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks
Time Frame
Baseline - 12 weeks
Title
Change in New York Heart Association (NYHA) class
Description
Change in NYHA class from Baseline to 12 weeks
Time Frame
Baseline to 12 weeks
Title
Change in 6 minute walk distance
Description
Change in 6 minute walk distance from Baseline to 12 weeks
Time Frame
Baseline to 12 weeks
Title
Quality of Life (QoL) based on Kansas City Cardiomyopathy Questionnaire (KCCQ) change
Description
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.
Time Frame
Baseline to 12 weeks
Title
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
Description
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
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
862-259-4382
Email
daniel.qi@vita-spes.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chen, MD
Organizational Affiliation
Innolife Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA School of Medicine
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Completed
Facility Name
Universal Axon Clinical Research
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Withdrawn
Facility Name
Grady Clinical Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Completed
Facility Name
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Trials of America LA, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Individual Site Status
Withdrawn
Facility Name
St Louis Heart and Vascular
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Completed
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Completed
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stern Cardiovascular
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Withdrawn
Facility Name
East Texas Cardiology
City
Houston
State/Province
Texas
ZIP/Postal Code
77002
Country
United States
Individual Site Status
Completed
Facility Name
Angiocardiac Care of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Individual Site Status
Completed
Facility Name
Chongqing University 3 Gorges Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lirong Qui
Phone
15523798618

12. IPD Sharing Statement

Plan to Share IPD
No

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

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