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New treatment option for Pulmonary Arterial Hypertension (PAH)
Official title PAH Exercise Study
ClinicalTrials.gov ID: NCT06941441
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
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
- 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...
- 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...
- Receiving stable background therapy for PAH for \>90 days and will continue receiving throughout trial. Background treatments may consist of...
You likely can't join if
- 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...
- 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...
- Pregnant or breastfeeding females
See the full eligibility 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...
- 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...
- 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
- 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...
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.