A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Recruiting · NCT07465653 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
HJB647 high doseHJB647 low dosePlacebo
What this trial is about
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).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
4 locations listed across 1 US state.
- Synergy Healthcare - Bradenton, Florida, United States
- Nature Coast Clinical Research LLC - Inverness, Florida, United States
- Jacksonville Center for Clinical - Jacksonville, Florida, United States
- Novartis Investigative Site - Montreal, Quebec, Canada