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โ† Trials
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A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction

RecruitingPhase 1Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ600 pg/ml if in sinus rhythm or โ‰ฅ900 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 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.
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What it tests

  • HJB647 low dose
  • HJB647 high dose
  • Placebo
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Where

6 sites
Synergy Healthcare
Bradenton, United States
Nature Coast Clinical Research LLC
Inverness, United States
Jacksonville Center for Clinical
Jacksonville, United States
Inpatient Research Clinical LLC
Miami Lakes, United States
Flourish Research
Winter Park, United States
Novartis Investigative Site
Montreal, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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