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

Launched by 35PHARMA INC · Aug 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called HS135 for obese patients who have two specific health issues: pulmonary hypertension (high blood pressure in the lungs) and heart failure with preserved ejection fraction (a condition where the heart pumps normally but still causes symptoms). The study aims to see if HS135 can help improve the health of these patients. It is currently looking for participants aged 18 and older who have been diagnosed with heart failure and have a Body Mass Index (BMI) of 30 or more, indicating obesity.

To be eligible for the study, participants must have a special heart monitoring device called the CardioMEMS™ implanted for at least 90 days and have specific heart failure symptoms. However, individuals with certain serious heart conditions or recent heart surgeries are not eligible to join. Those who participate can expect regular visits and monitoring throughout the study to track their health and response to the treatment. Overall, this trial is an important step in finding new ways to help patients with these challenging conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients are eligible to be included in the study only if they meet at least all the following 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.
• Exclusion Criteria:
• Patients will be excluded from the study if they meet any of the following criteria:
• • 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.