Testing HJB647 low dose against a placebo for heart failure with reduced ejection fraction
Official title: A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Crossover Study to Investigate the Safety, Tolerability, and Pharmacokinetics of HJB647 in Participants With Chronic Stable Heart Failure With Reduced Ejection Fraction
- Phase 1
- 3 groups
- One site, in Montreal
- Recruiting
Interventions
- Medication
HJB647 low dose
Study drug low dose in capsule form
- Medication
HJB647 high dose
Study drug high dose in capsule form
- Other intervention
Placebo
Placebo control in capsule form
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec
Eligibility Criteria
See who this study is looking for16 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in this study must meet all of the following criteria:
- +Men and women aged 18 years or older
- +Stable NYHA functional class II-III
- +LVEF \<50%
- +NT-proBNP ≥600 pg/ml if in sinus rhythm or ≥900 pg/ml if in atrial fibrillation at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- +On stable standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → therapy with sacubitril/valsartan for at least 4 weeks before screening.
Exclusion
- −Participants will be deemed ineligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → if they meet any of the following exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −Acute decompensated heart failure within 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −SBP \<105 mmHg at screening or baselineBaselineYour starting measurements, taken before treatment begins.Read more →.
- −Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation at screening
- −eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula
- −BMI \>40 kg/m2
- −Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products
- −Further eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → might apply in alignment with the trial protocolProtocolThe detailed plan a study must follow.Read more →.
- −Women of childbearing potential
- −Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty within the 6 months prior to screening
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: A: Placebo
Group B receives HJB647 low dose.
Registry label: B: HJB647 low dose
Group C receives HJB647 high dose.
Registry label: C: HJB647 high dose
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 100 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 12 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: Up to 33 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Up to 33 days.
Number of participants with clinically significant changes in vital signs — measured over Up to 33 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07465653 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About HJB647 low doseDrug
Study drug low dose in capsule form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About HJB647 high doseDrug
Study drug high dose in capsule form
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Placebo control in capsule form
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 100 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 100 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 33 days.
The study as a whole is currently expected to finish around 2026-12-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 12 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of HJB647 at two different doses in participants with chronic stable heart failure with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF).
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
Ask someone to help you approach it
Someone at Concord will read your request and email you. The study team decides who takes part.
Or answer a few questions to see which studies in Canada are closest to what you described.
This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.