Sotatercept for Pulmonary Arterial Hypertension
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the medication sotatercept can improve lung function in people with pulmonary arterial hypertension (PAH), a condition where narrow blood vessels in the lungs make breathing difficult. Participants will receive the medication every three weeks and visit the clinic to monitor lung and heart responses. It suits those diagnosed with PAH, experiencing symptoms like shortness of breath, and already on stable PAH treatment. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. In fact, participants must be on stable doses of at least two background PAH therapies for at least 60 days before the trial, so you may need to continue your current PAH medications.
What is the safety track record for this treatment?
Research has shown that sotatercept is generally safe for people with pulmonary arterial hypertension (PAH). Studies have found that it improves symptoms and heart function in patients. The safety profile of sotatercept is positive, indicating that most people tolerate it well. One study found that it lowers the risk of death and hospitalization compared to a placebo.
In summary, sotatercept shows promise in improving health outcomes for PAH patients, with reports of it being well-tolerated by those who have taken it.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about sotatercept for pulmonary arterial hypertension (PAH) because it introduces a novel mechanism of action. Unlike standard treatments like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogs, which primarily target blood vessel constriction and dilation, sotatercept works by targeting the TGF-beta superfamily signaling. This approach has the potential to address the underlying vascular remodeling seen in PAH, offering a fresh perspective on managing the condition. By potentially reversing pathological changes in blood vessels, sotatercept could provide a significant advantage over existing therapies, making it a promising option for patients.
What evidence suggests that sotatercept might be an effective treatment for pulmonary arterial hypertension?
Research has shown that sotatercept is effective for treating pulmonary arterial hypertension (PAH). In earlier studies, sotatercept improved patients' ability to exercise and slowed the progression of their condition. It proved especially beneficial for those who began treatment within a year of diagnosis. The treatment was linked to a lower risk of death, lung transplant, and hospital stays due to worsening PAH. Sotatercept reduced the risk of the condition worsening by 84% compared to those not receiving the treatment. These findings support its effectiveness in managing PAH. Participants in this trial will receive sotatercept to further evaluate its benefits for PAH.46789
Who Is on the Research Team?
Michael Stickland, PhD
Principal Investigator
University of Alberta
Jason Weatherald, MD
Principal Investigator
University of Alberta
Are You a Good Fit for This Trial?
This trial is for adults with pulmonary arterial hypertension (PAH), including idiopathic PAH, drug/toxin-induced PAH, and PAH associated with other conditions. Participants must be on stable doses of at least two PAH therapies or have a documented intolerance to specific treatments. They should not be pregnant and agree to use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Sotatercept every 21 days with regular assessments and monitoring
End-of-Study
Final assessments and evaluations are conducted after the last dose of the study medication
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment with open-label sotatercept
What Are the Treatments Tested in This Trial?
Interventions
- Sotatercept
Trial Overview
The trial tests if Sotatercept can improve lung function in people with PAH. Over 29 weeks, participants will receive Sotatercept every three weeks, attend clinic visits for physical exams, lung function assessments, exercise tests, heart ultrasounds, and regular blood draws.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Sotatercept 0.7mg/kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor
Merck Canada Inc.
Industry Sponsor
Alberta Health services
Collaborator
Citations
Sotatercept in Patients with Pulmonary Arterial ...
Background: Sotatercept improves exercise capacity and delays the time to clinical worsening in patients with World Health Organization (WHO) ...
Sotatercept Beneficial in Recent-Onset Pulmonary Arterial ...
The activin-signaling inhibitor improved clinical outcomes in patients when given within 1 year of PAH diagnosis. ... PAH based on trials in those ...
Early Outcomes of Sotatercept in Pulmonary Arterial ...
Mean RVFWS improved to -19% [-21% to -14.6%] (p = 0.032). Side effects were infrequent, except for an increment in Hb levels by a mean 1.92±1.4 g/dL (p<0.0001).
Sotatercept In High-Risk Patients With Pulmonary Arterial ...
Treatment with sotatercept resulted in a lower risk of all-cause death, lung transplantation, and hospitalization (≥24 hours) for worsening PAH than placebo.
The effectiveness and value of sotatercept for pulmonary ...
There was an 84% reduction in the risk of clinical worsening with sotatercept as assessed by a composite endpoint of time to first clinical ...
Clinical outcomes and safety of sotatercept in pulmonary ...
Sotatercept significantly improves functional and hemodynamic outcomes in PAH, with a favorable safety profile. While mortality benefits remain uncertain.
A New Frontier in Pulmonary Arterial Hypertension Treatment
Data synthesis: The findings from this review indicate that sotatercept is an overall safe and effective option for improving PAH outcomes when ...
Phase 3 Trial of Sotatercept for Treatment of Pulmonary ...
Improvements were observed within the first 24 weeks of treatment and maintained over a period of 18 to 24 months with continued sotatercept therapy. In the ...
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ajmc.com
ajmc.com/view/sotatercept-for-pah-maintains-safety-reduced-mortality-in-long-term-follow-upSotatercept for PAH Maintains Safety, Reduced Mortality in ...
Sotatercept significantly reduced mortality risk by 85% in patients with PAH compared with placebo. The safety profile of sotatercept remained ...
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