No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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 3
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for people with stable pulmonary arterial hypertension (PAH) who can start a new treatment called sotatercept. Participants will take sotatercept and follow a personalized home exercise program, monitored remotely, for 26 weeks.
Are You a Good Fit for This Trial?
Rules you outPortal hypertensionChronic liver diseaseLong QT syndrome
You may be able to join if
I am at least 18 years old.
I have been diagnosed with pulmonary arterial hypertension.
I have symptoms of pulmonary hypertension that are classified as WHO FC II or III.
I have stable background therapy for PAH for more than 90 days.
I am willing to follow a home exercise program for 24 weeks.
I can understand and sign consent forms.
You may not be able to join if
I do not have pulmonary hypertension from the correct groups.
I have uncontrolled high blood pressure.
I am pregnant or breastfeeding.
I have had a serious heart-related problem in the last 6 months.
I have had liver or kidney function tests that are not normal.
I have had certain heart diseases or procedures recently.
I have received certain medications in the last 30 days.
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.
Ten patients with PAH who are stable and eligible to initiate sotatercept therapy will participate in a 26 week study that consists of a 24-week intervention period where patients will receive complimentary sotatercept as prescribed, plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥ 18 years
* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with CTD, PAH associated …
Inclusion Criteria:
* Age ≥ 18 years
* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with CTD, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
* Symptomatic PH classified as WHO FC II or III
* Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 WU and a pulmonary capillary wedge (PCWP) or left ventricular end-diastolic pressure of ≤ 15 mmHg
* Receiving stable background therapy for PAH for \>90 days and will continue receiving throughout trial. Background treatments may consist of monotherapy, double therapy, or triple therapy with currently available medications for PAH.
* Initiation of Sotatercept is clinically indicated
* Willing and able to participate in a remotely-monitored home exercise program for 24 weeks
* Ability to adhere to study visit schedule and understand and comply with all protocol requirements
* Ability to understand and provide written informed consent
Exclusion Criteria:
* Diagnosis of PH WHO Groups 2, 3, 4, or 5
* Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease
* Hemoglobin at screening above gender-specific ULN
* Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) at screening
* Uncontrolled systemic hypertension as evidenced by sitting systolic BP \> 160 mmHg or sitting diastolic BP \> 100 mmHg during screening visit after a period of rest; Baseline systolic BP \< 90 mmHg at screening
* Pregnant or breastfeeding females
* Clinical laboratory liver and kidney function tests outside of normal range
* Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent
* Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536) or known allergic reaction to either one
* History of full pneumonectomy
* Initiation of a structured exercise program within 90 days prior or planned initiation during the study
* Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).
* Cardiac related history: History of restrictive, constrictive, or congestive cardiomyopathy; History of atrial septostomy within 180 days prior to the screening visit; ECG with Fridericia's corrected QT interval (QTcF) \> 500 ms during the Screening Period; Personal or family history of long QT syndrome (LQTS) or sudden cardiac death; Left ventricular ejection fraction (LVEF) \< 45% on historical ECHO within 12 months prior to the screening visit; Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions
* Cerebrovascular accident within 3 months prior to the screening visit
* Acutely decompensated heart failure within 14 days prior to the screening visit, as per investigator assessment
* Significant (≥ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
* Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
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