Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

• 1. Male or female, \>18 years of age.
• 2. CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
• 3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
• 4. New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
• 5. BMI ≥ 30 kg/m2.
• 6. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
• 1. Decompensated heart failure.
• 2. Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
• 3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
• 4. Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
• 5. History of heart transplant or on heart transplant list.
• 6. Uncontrolled systemic hypertension.
• 7. Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
• 8. Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.