Pulmonary Hypertension study: HS235
Official title HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT07123779
What this study is testing
What is HS235?
HS235 is an investigational biological medicine being studied as a potential treatment for pulmonary hypertension in people with heart failure with preserved ejection fraction.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to evaluate the safety and early effectiveness of HS235 in people with combined pre‑ and post‑capillary pulmonary hypertension due to heart failure with preserved ejection fraction.
- Who it's for
- Adults who are overweight or obese and have combined pre‑ and post‑capillary pulmonary hypertension caused by heart failure with preserved ejection fraction.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, ≥ 18 years of age.
- 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...
- 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...
- 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...
- PVR ≥ 240 dyn\ sec/cm5 or ≥ 3 WU, and
You likely can't join if
- 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.
- History of heart transplant or on heart transplant list.
- History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
See the full eligibility criteria
- Male or female, ≥ 18 years of age.
- 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,
- 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.
- 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.
- PVR ≥ 240 dyn\ sec/cm5 or ≥ 3 WU, and
- mPAP \> 20 mmHg, and
- PAWP \> 15 mmHg but \< 30 mmHg, and
- dPAP ≥ 15 mmHg.
- Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening and and no documented LVEF \< 45% during the 2 years preceding 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 ≥ 25 to ≤ 50 kg/m2 and Body weight ≤140 kg.
- Ability to adhere to study visit schedule and understand and comply with all protocol requirements.
- 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.
- History of heart transplant or on heart transplant list.
- History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
- Systemic hypotension or uncontrolled systemic hypertension.
- History of Pericardial constriction or hypertrophic cardiomyopathy.
- History of significant valvular stenosis or regurgitation.
- Participants with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or untreated mild obstructive sleep apnea (OSA).
The study team makes the final eligibility decision.
Where it is enrolling
- Kansas City, Missouri, United States
- Greenville, South Carolina, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kansas City, Missouri, United States; Greenville, South Carolina, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.