Status:
TERMINATED
Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
35Pharma Inc
Conditions:
Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Detailed Description
Phase 1b, Multicenter, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients with Pulmonary ...
Eligibility Criteria
Inclusion
- Patients are eligible to be included in the study only if they meet at least all the following criteria:
- Male or female, \>18 years of age.
- CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening.
- Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening.
- New York Heart Association (NYHA) class II, III or IV heart failure symptoms.
- BMI ≥ 30 kg/m2.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
Exclusion
- Patients will be excluded from the study if they meet any of the following criteria:
- Decompensated heart failure.
- Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening.
- Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening.
- Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device.
- History of heart transplant or on heart transplant list.
- Uncontrolled systemic hypertension.
- Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.
- 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.
Key Trial Info
Start Date :
January 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06581159
Start Date
January 23 2025
End Date
July 29 2025
Last Update
September 4 2025
Active Locations (2)
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1
Site-104
Phoenix, Arizona, United States, 85016
2
Site-105
Kansas City, Missouri, United States, 64111