Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Eje… (NCT07123779) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)
40 participantsStarted 2025-09
Plain-language summary
Study of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, ≥ 18 years of age.
. Ambulatory pulmonary artery pressure (PAP) monitoring (e.g. CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening with mean pulmonary artery pressure (mPAP) ≥ 25 mmHg and diastolic pulmonary artery pressure(dPAP) ≥ 15 mmHg as averaged over the last 2 weeks prior to Randomization.
. Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening.
. New York Heart Association (NYHA) class II or III heart failure symptoms.
. Stable diuretic regimen during the screening period.
. Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \< 90 at screening.
. 6-minute walking distance (6MWD) ≥ 100 m at screening.
. Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg.
Exclusion criteria
. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.