Sotatercept in Pulmonary Arterial Hypertension
ConditionPulmonary Artery Hypertension
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.
Participants will be asked to:
* Take Sotatercept every 21 days (±3 days) * Each participant will be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals
The main objectives of the study are:
Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.
Secondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Idiopathic PAH
Heritable PAH
Drug/toxin-induced PAH
Disqualifiers
1. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
Musculoskeletal limitation that precludes participation in cycle ergometry
Resting oxygen saturation < 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).
Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.
Trial design
Design model
Single group
Treatments tested in this trial
Sotatercept
Drug0.7mg/kg
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Sotatercept GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lung diffusing capacity
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Time frame
6 weeks post starting treatment2
Lung diffusing capacity
Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Time frame
23 weeks post starting treatment3
Diffusing membrane capacity (Dm)
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Time frame
6 weeks post starting treatment4
Diffusing membrane capacity (Dm)
Diffusing membrane capacity will be measured using six-second, advanced DLCO
Time frame
23 weeks post starting treatmentSecondary outcomes
1
Cardiac structure and function
Cardiac structure will be measured using standard cardiac ultrasound
Time frame
6 weeks post starting treatment2
Cardiac structure and function
Cardiac structure will be measured using standard cardiac ultrasound
Time frame
23 weeks post starting treatment3
Cardiac function
Cardiac function will be measured using standard cardiac ultrasound
Time frame
6 weeks post starting treatment4
Cardiac function
Cardiac function will be measured using standard cardiac ultrasound
Time frame
23 weeks post starting treatmentSponsors and contacts
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Source ClinicalTrials.gov