A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT07465653, who can take part
Where in Canada
- MontrealMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07465653
- Record updated
- 1 October 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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 for at least 4 weeks before screening.
Exclusion: Acute decompensated heart failure within 3 months prior to screening; 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; Strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products; eGFR <30 ml/min/1.73m2 at screening, as measured by the CKD-EPI formula; Participants will be deemed ineligible for inclusion if they meet any of the following exclusion criteria:; SBP <105 mmHg at screening or baseline; BMI >40 kg/m2; Women of childbearing potential; Further eligibility criteria might apply in alignment with the trial protocol.