Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)

Korábbi kezelés

• 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
• Implantation of a CRT device within 3 months prior to screening or intent to implant a CRT during the study period
• Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4 weeks from screening
• Cohort 2: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening

Más betegség

• Hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to LV dilatation at screening
• History of severe pulmonary disease (e.g. COPD) requiring chronic supplemental oxygen therapy or pulmonary hypertension requiring pharmacology treatment at Screening

Laborértékek

• eGFR \<45 mL/min/1.73 m2 at screening

Egyéb

• BMI \>40 kg/m2
  • Other protocol-specific criteria may apply.

• NYHA functional class II-III
• LVEF ≤ 50% documented at screening
• Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive
• Treatment with a stable dose of a beta blocker.
• Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB
• Cohort 2: Treatment with a stable dose of sacubitril/valsartan.