RecruitingPulmonary HypertensionHeart Failure With Preserved Ejection Fraction
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
Sponsor: 35Pharma Inc
You may qualify if…
- ✓ Participants 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. \[Sub-population A only - using a remote PAP sensor\]- Ambulatory 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.
- ✓ Hemodynamic evidence of PH with:
- ✓ 1. mPAP ≥ 25 mm Hg, as measured by the ambulatory PAP monitoring system in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND,
- ✓ 2. dPAP ≥ 15 mm Hg, as measured by the ambulatory PAP monitoring system in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.
- ✓ 3. Hemodynamic evidence of pre-capillary PH based on presence of PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU obtained on most recent RHC obtained prior to screening.
- ✓ 3. \[Sub-population B only - without a remote PAP sensor\]
You may not qualify if…
- ✕ 1. Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
- ✕ 2. Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
- ✕ 3. Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
- ✕ 4. Planned cardiovascular revascularization or planned implantation of CRT device.
- ✕ 5. History of heart transplant or on heart transplant list.
- ✕ 6. History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
- ✕ 7. Systemic hypotension or uncontrolled systemic hypertension.
- ✕ 8. History of Pericardial constriction or hypertrophic cardiomyopathy.
Where it's recruiting
Missouri
Kansas City
South Carolina
Greenville
Source: ClinicalTrials.gov · NCT07123779 · last updated 2026-09-29