Heart FailurePhase 2TRACER-HFNCT03875183
Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
A Phase 2 study testing INL1 in people with Heart Failure and Reduced Ejection Fraction, run by Innolife Co., Ltd. at 13 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Reduced Ejection Fraction
- What is being tested?
- INL1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 20 Jan 2020to Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
- Completed
Grady Clinical Research Center
Atlanta, Georgia, 30303
- Completed
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756
- Withdrawn
Universal Axon Clinical Research
Doral, Florida, 33166
- Completed
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
- Withdrawn
Stern Cardiovascular
Germantown, Tennessee, 38138
- Withdrawn
Medication Management, LLC
Greensboro, North Carolina, 27401
- Completed
East Texas Cardiology
Houston, Texas, 77002
- Completed
Angiocardiac Care of Texas
Houston, Texas, 77025
- Withdrawn
Clinical Trials of America LA, LLC
Monroe, Louisiana, 71203
- Completed
St Louis Heart and Vascular
St Louis, Missouri, 63136
- Active, not recruiting
UCLA School of Medicine
Torrance, California, 90502
- Withdrawn
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, 67214
China1 site, 1 recruiting
- Recruiting
Chongqing University 3 Gorges Hospital
Chongqing
Lirong Qui, 15523798618
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
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).
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Being tested
- INL1, Placebo
- Keywords
- Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INL1Drug
Capsules
PlaceboOther
Capsules
| Study group | Role | What they receive |
|---|---|---|
| INL1 50mg BID | Experimental | INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose Receives: Drug: INL1 |
| INL1 150 mg BID | Experimental | INL1 150mg dose to be given twice daily using three 50mg capsules at each dose Receives: Drug: INL1 |
| INL1 300 mg BID | Experimental | INL1 300mg dose to be given twice daily using three 100mg capsules at each dose Receives: Drug: INL1 |
| Placebo | Placebo comparator | Placebo dose to be given twice daily using 3 placebo capsules at each dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline - 12 weeks
Secondary outcomes (22)
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
Measured: Baseline - 12 weeks
Change in Left Ventricular End Diastolic (LVED)
Echocardiogram finding: change in LVED from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular End Systolic (LVES)
Echocardiogram finding: change in LVES from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular End Diastolic Volume (LVEDV)
Echocardiogram finding: change in LVEDV from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular End Systolic Volume (LVESV)
Echocardiogram finding: change in LVESV from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular Systolic Volume (LVSV)
Echocardiogram finding: change in LVSV from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular Ejection Fraction (LVEF)
Echocardiogram finding: change in LVEF from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular Mass (LVM)
Echocardiogram finding: change in LVM from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular End Diastolic Diameter (LVEDD)
Echocardiogram finding: change in LVEDD from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular End Systolic Diameter (LVESD)
Echocardiogram finding: change in LVESD from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Left Ventricular Fractional Shortening (LVFS)
Echocardiogram finding: change in LVFS from Baseline to 12 weeks
Measured: Baseline - 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
Measured: Baseline - 12 weeks
Change in Left Atrial Volume (LAV)
Echocardiogram finding: change in LAV from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Echocardiogram finding: change in TAPSE from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) peak velocity
Echocardiogram finding: change in TR peak velocity from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) gradient
Echocardiogram finding: change in TR gradient from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) severity
Echocardiogram finding: change in TR severity from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in Inferior Vena Cava (IVC) Diameter
Echocardiogram finding: change IVC Diameter from Baseline to 12 weeks
Measured: Baseline - 12 weeks
Change in New York Heart Association (NYHA) class
Change in NYHA class from Baseline to 12 weeks
Measured: Baseline to 12 weeks
Change in 6 minute walk distance
Change in 6 minute walk distance from Baseline to 12 weeks
Measured: 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.
Measured: Baseline to 12 weeks
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
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start20 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innolife Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Chen, MD, Study chair, Innolife Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875183
- Sponsor's protocol ID
- INL1-001
- Other IDs
- 2019-000511-89, 2019
- Acronym
- TRACER-HF
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT03875183
- Acronym / sponsor ID
- TRACER-HF / INL1-001
- Conditions
- Heart Failure, Reduced Ejection Fraction
- Keywords
- Heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Innolife Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INL1 50mg BID | Experimental | Drug: INL1INL1 50mg dose to be given twice daily using one 50mg capsule and two matching placebo capsules at each dose |
| INL1 150 mg BID | Experimental | Drug: INL1INL1 150mg dose to be given twice daily using three 50mg capsules at each dose |
| INL1 300 mg BID | Experimental | Drug: INL1INL1 300mg dose to be given twice daily using three 100mg capsules at each dose |
| Placebo | Placebo comparator | Other: PlaceboPlacebo dose to be given twice daily using 3 placebo capsules at each dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INL1Capsules | Drug | INL1 150 mg BID, INL1 300 mg BID, INL1 50mg BID |
| PlaceboCapsules | Other | Placebo |
Primary outcome
Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time frame: Baseline - 12 weeks
Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) from Baseline to 12 weeks
22 secondary outcomes
Composite Heart Failure (HF) Improvement Score
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Diastolic (LVED)
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Systolic (LVES)
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Diastolic Volume (LVEDV)
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Systolic Volume (LVESV)
Time frame: Baseline - 12 weeks
Change in Left Ventricular Systolic Volume (LVSV)
Time frame: Baseline - 12 weeks
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline - 12 weeks
Change in Left Ventricular Mass (LVM)
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Diastolic Diameter (LVEDD)
Time frame: Baseline - 12 weeks
Change in Left Ventricular End Systolic Diameter (LVESD)
Time frame: Baseline - 12 weeks
Change in Left Ventricular Fractional Shortening (LVFS)
Time frame: Baseline - 12 weeks
Change in ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')
Time frame: Baseline - 12 weeks
Change in Left Atrial Volume (LAV)
Time frame: Baseline - 12 weeks
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Time frame: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) peak velocity
Time frame: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) gradient
Time frame: Baseline - 12 weeks
Change in Tricuspid Regurgitation (TR) severity
Time frame: Baseline - 12 weeks
Change in Inferior Vena Cava (IVC) Diameter
Time frame: Baseline - 12 weeks
Change in New York Heart Association (NYHA) class
Time frame: Baseline to 12 weeks
Change in 6 minute walk distance
Time frame: Baseline to 12 weeks
Quality of Life (QoL) based on Kansas City Cardiomyopathy Questionnaire (KCCQ) change
Time frame: Baseline to 12 weeks
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 frame: Baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chen, MD study chair
Innolife Co., Ltd.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INL1 in people with Heart Failure and Reduced Ejection Fraction, run by Innolife Co., Ltd. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Director (862-259-4382, daniel.qi@vita-spes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportional change in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (time frame: Baseline - 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.