Actively Recruiting
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Led by Novartis Pharmaceuticals · Updated on 2026-04-15
12
Participants Needed
3
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
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).
CONDITIONS
Official Title
A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years or older
- Stable NYHA functional class II-III
- Left ventricular ejection fraction less than 50%
- NT-proBNP 600 pg/ml or higher if in sinus rhythm, or 900 pg/ml or higher if in atrial fibrillation at screening
- On stable standard of care therapy with sacubitril/valsartan at a dose of at least 49/51 mg twice daily for at least 4 weeks before screening
You will not qualify if you...
- Acute decompensated heart failure within 3 months prior to screening
- Systolic blood pressure less than 105 mmHg at screening or baseline
- Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, percutaneous coronary intervention, or carotid angioplasty within 6 months prior to screening
- Hemodynamically significant mitral and/or aortic valve disease, or any prior valve replacement, except mitral regurgitation secondary to left ventricular dilation at screening
- Estimated glomerular filtration rate less than 45 ml/min/1.73m2 at screening
- Body mass index greater than 40 kg/m2
- Use of strong CYP3A4 inhibitors or inducers, sGC activators (vericiguat), PDE5 inhibitors, and nitroglycerin products
- Women of childbearing potential
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Synergy Healthcare
Bradenton, Florida, United States, 34208
Actively Recruiting
2
Nature Coast Clinical Research LLC
Inverness, Florida, United States, 34452
Actively Recruiting
3
Jacksonville Center for Clinical
Jacksonville, Florida, United States, 32216
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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