HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Phase 1b/2, Multicenter, Double-Blind, Placebo-Controlled, Multiple Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS235 in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests HS235 in adults who are overweight or obese and have high blood pressure in the lungs linked to heart failure. It is for people whose heart still pumps out a mostly preserved share of blood with each beat.
Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old and able to follow study rules and attend visits.
- Meet the study’s lung blood pressure and blood flow limits. Testing differs based on whether you have an implanted pressure sensor.
- If you use a remote lung pressure sensor, it must have been implanted as part of usual care at least 90 days before screening.
- Have heart failure with an ejection fraction of at least 45% on a heart ultrasound, with no recorded value below 45% in the past 2 years. This is the share of blood pumped out with each beat.
- Have heart failure symptoms that limit ordinary activity or activity lighter than usual, and take a stable dose of water pills during screening.
- Score below 90 on the study’s heart failure symptom and daily activity survey.
- Be able to walk at least 100 meters in 6 minutes at screening.
- Have a body mass index (BMI) from 25 to 50 and weigh no more than 140 kilograms. BMI is a measure based on height and weight.
Who can't join
- A hospital stay for worsening health or major surgery in the 4 weeks before screening.
- A sudden problem with blood flow to the heart, a procedure to open heart arteries, heart surgery, or placement of a heart-pacing device called CRT in the past 90 days.
- Plans for a procedure to restore blood flow to the heart or to place a CRT device.
- A past heart transplant or being on a heart transplant waiting list.
- A serious or life-threatening heart rhythm problem in the past 90 days.
- Low blood pressure or high blood pressure that is not controlled.
- A history of a tight sac around the heart, an abnormally thick heart muscle, or serious narrowing or leaking of heart valves.
- Removal of a whole lung; COPD, a long-term lung disease, that is worse than moderate; mild interstitial lung disease, which affects tissue around the lung’s air sacs; or untreated mild sleep apnea, which causes breathing pauses during sleep.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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. \[Sub-population B only - without a remote PAP sensor\] Hemodynamic evidence of Cpc-PH based on the presence of all the following RHC parameters obtained during the Screening period, prior to randomization: 1. PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU, and 2. mPAP \> 20 mmHg, and 3. PAWP \> 15 mmHg but \< 30 mmHg, and 4. dPAP ≥ 15 mmHg. 4. 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.. 5. New York Heart Association (NYHA) class II or III heart failure symptoms. 6. Stable diuretic regimen during the screening period. 7. Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \< 90 at screening. 8. 6-minute walking distance (6MWD) ≥ 100 m at screening. 9. Body mass index ≥ 25 to ≤ 50 kg/m2 and Body weight ≤140 kg. 10. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. Exclusion Criteria: 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. 9. History of significant valvular stenosis or regurgitation. 10. 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).
Study sites (2)
MO
- Investigational Site-105 · Kansas City, MO 64111More trials in Kansas City
SC
- Investigational Site-101 · Greenville, SC 29605More trials in Greenville