HS235 Study in Obese Participants With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor35Pharma Inc
About this trial
Study of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
Eligibility criteria
Qualifiers
Male or female, ≥ 18 years of age.
[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.
mPAP ≥ 25 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND,
dPAP ≥ 15 mm Hg, as measured in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.
Disqualifiers
Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
Planned cardiovascular revascularization or planned implantation of CRT device.
Trial design
Treatments tested in this trial
- HS235
- Placebo
Treatment groups
126 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov