Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
TRACER-HF
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
2 other identifiers
interventional
200
2 countries
13
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started Jan 2020
Typical duration for phase_2 heart-failure
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedMarch 31, 2022
March 1, 2022
2.9 years
March 12, 2019
March 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Composite Heart Failure (HF) Improvement Score
Baseline - 12 weeks
Change in Left Ventricular End Diastolic (LVED)
Baseline - 12 weeks
Change in Left Ventricular End Systolic (LVES)
Baseline - 12 weeks
Change in Left Ventricular End Diastolic Volume (LVEDV)
Baseline - 12 weeks
Change in Left Ventricular End Systolic Volume (LVESV)
Baseline - 12 weeks
- +17 more secondary outcomes
Study Arms (4)
INL1 50mg BID
EXPERIMENTALINL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose
INL1 150 mg BID
EXPERIMENTALINL1 150mg dose to be given twice daily using three 50mg capsules at each dose
INL1 300 mg BID
EXPERIMENTALINL1 300mg dose to be given twice daily using three 100mg capsules at each dose
Placebo
PLACEBO COMPARATORPlacebo dose to be given twice daily using 3 placebo capsules at each dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
UCLA School of Medicine
Torrance, California, 90502, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Universal Axon Clinical Research
Doral, Florida, 33166, United States
Grady Clinical Research Center
Atlanta, Georgia, 30303, United States
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, 67214, United States
Clinical Trials of America LA, LLC
Monroe, Louisiana, 71203, United States
St Louis Heart and Vascular
St Louis, Missouri, 63136, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 28054, United States
Medication Management, LLC
Greensboro, North Carolina, 27401, United States
Stern Cardiovascular
Germantown, Tennessee, 38138, United States
East Texas Cardiology
Houston, Texas, 77002, United States
Angiocardiac Care of Texas
Houston, Texas, 77025, United States
Chongqing University 3 Gorges Hospital
Chongqing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Chen, MD
Innolife Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
January 20, 2020
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share