HJB647 low dose: Study drug low dose in capsule form
HJB647 high dose: Study drug high dose in capsule form
Placebo: Placebo control in capsule form
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion 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.
Exclusion Criteria:
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.
Primary outcome measure(s)
Number of participants with Adverse Events (AEs) — Up to 33 days Number of participants with AEs as a measure of safety and tolerability
Number of participants with clinically significant changes in vital signs — Up to 33 days Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.