A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HJB647 low dose
- HJB647 high dose
- Placebo
Treatment groups
12 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov