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Tests treatment safety and results for Heart Failure With Reduced Ejection Fraction
Official title A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT07465653
What this study is testing
What is HJB647 low dose?
HJB647 low dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Participants eligible for inclusion 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 screening
You likely can't join if
- Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:
- Acute decompensated heart failure within 3 months prior to screening
- SBP \<105 mmHg at screening or baseline.
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, PCI, or carotid angioplasty...
- Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to LV dilation...
- eGFR \<30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula
See the full eligibility criteria
- Participants eligible for inclusion 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 screening
- On stable standard of care therapy with sacubitril/valsartan with a dose of at least 49/51 mg BID for at least 4 weeks before screening.
- Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:
- Acute decompensated heart failure within 3 months prior to screening
- SBP \<105 mmHg at screening or baseline.
- 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
- 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
- Women of childbearing potential Further eligibility criteria might apply in alignment with the trial protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Bradenton, Florida, United States
- Inverness, Florida, United States
- Jacksonville, Florida, United States
- Montreal, Quebec, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bradenton, Florida, United States; Inverness, Florida, United States; Jacksonville, Florida, United States; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.