Study of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Megadott ok: Sponsor's Decision
Key facts
- Where
- Kansas City és Phoenix, Egyesült ÁllamokSee the 2 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- Kansas CityKansas City, Egyesült ÁllamokNo longer taking part
- PhoenixPhoenix, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- 35Pharma Inc., a GSK company
- Trial code
- NCT06581159
- Record updated
- 2025. szeptember 4.
- Original description
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)Read full original descriptionShow less
Phase 1b Double-Blind, Placebo-Controlled, MAD Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
A Study of HS135 for the Treatment of in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
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: 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; Decompensated heart failure; 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 full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study; Patients will be excluded from the study if they meet any of the following criteria:; Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study.