HS235 Treatment for Pulmonary Hypertension and Heart Failure
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Recruiting
Phase 1Phase 2Interventional Study
Pulmonary HypertensionHeart Failure With Preserved Ejection Fraction
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
35Pharma Inc · Industry
Who this trial is looking for
This trial is looking for obese adults with pulmonary hypertension and heart failure. Participants will be evaluated for their symptoms and heart function before starting the trial treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with heart failure with preserved ejection fraction.
I am experiencing class II or III heart failure symptoms.
I have a body mass index between 30 and 50.
I can walk at least 100 meters in 6 minutes.
I have had stable diuretic medication during screening.
I do not have a left ventricular ejection fraction lower than 45% in the past 2 years.
You may not be able to join if
I have been hospitalized for a worsening condition in the past 4 weeks.
I have had a heart attack or heart surgery in the past 90 days.
I have had a cardiac resynchronization therapy device implanted in the past 90 days.
I have a serious heart condition or history of serious arrhythmias in the past 90 days.
I have uncontrolled high blood pressure.
I have a history of significant heart or lung diseases.
I have undergone a pneumonectomy or have severe COPD.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 Sy…
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).
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.