Sotatercept in Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Artery Hypertension
- Interventions
- Registration Number
- NCT07140484
- Lead Sponsor
- University of Alberta
- Brief Summary
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 15 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.
- Detailed Description
Potential participants must provide their written informed consent before any study-specific procedures.
All screening procedures will be completed over two weeks during three separate visits. For participants from the Calgary site (site 2), all Visit 1 procedures except for PFT and CPET may be performed on a separate day in Calgary. Visits 2 and 3 will be performed in Edmonton (site 1). According to patient preference, visits 2 and 3 can be performed on the same day, with a minimum 3-hour break between visits. For participants from the Calgary (site 2), the first drug administration will occur in Calgary within seven days of completion of Visit 3 procedures.
Screening will include reviewing the participant's medical, surgical, and family history, collecting demographics, race, and ethnicity, and requesting medical records for relevant external procedures.
Screening procedures include:
Visit 1:
* Informed consent
* Inclusion/exclusion criteria
* Medical history review
* Physical examination
* 12-lead ECG
* Vital signs
* Weight
* WHO FC assessment
* Pregnancy test
* Hematology (complete blood count)
* Hemoglobin
* Serum chemistry
* NT-proBNP
* PFT
* CPET
* QoL assessments
* AE/SAE Review
* Concomitant medication review
Visit 2:
* Hemoglobin
* Rest/exercise DLCO, VC, DM
* Rest/exercise CW-NIRS
* AE/SAE Review
* Concomitant medication review
Visit 3:
* Pregnancy test
* Rest/exercise Echocardiography
* AE/SAE Review
* Concomitant Medication review
* Study drug administration
Measurements/assessments taken during the Screening Period will be recorded as the baseline values for the study assessment of endpoints.
Treatment Period (Visit 4-11) All study procedures should be performed prior to the study drug administration. For participants at the Calgary site, Visits 4-11 occur at their home site.
Visit 4-6 (every 3 weeks):
* Focused cardiopulmonary physical examination
* Vital signs
* Weight
* WHO FC assessment
* Pregnancy test
* Hematology
* Clinical worsening assessment
* AE/SAE Review
* Concomitant medication review
Visit 7:
* Focused cardiopulmonary physical examination
* Vital signs
* Weight
* WHO FC assessment
* Pregnancy test
* Hematology
* Serum chemistry
* NT-proBNP
* Clinical worsening assessment
* AE/SAE Review
* Concomitant medication review
Visit 8-11 (every 3 weeks):
* Focused cardiopulmonary physical examination
* Vital signs
* Weight
* WHO FC assessment
* Pregnancy test
* Hematology
* Clinical worsening assessment
* AE/SAE Review
* Concomitant medication review
End-of-Study Period (Visits 12-14) End-of-Study period visits will start 1 week after the last dose of the study medication and will be completed over 2 weeks. For participants in the Calgary site (site 2), all Visit 12 procedures except for PFT and CPET may be performed on a separate day in Calgary. Visits 13 and 14 will be performed in Edmonton (site 1). Visit 13 and 14 can be performed on the same day according to patient preference, with a minimum 3-hour break between visits.
Visit 12:
* Physical examination
* Weight
* Hemoglobin
* PFT
* CPET
* QoL Assessment
* AE/SAE Review
* Concomitant medication review
Visit 13:
* Hemoglobin
* Rest/exercise DLCO, VC, DM
* Rest/exercise CW-NIRS
* AE/SAE Review
* Concomitant medication review
Visit 14:
* Rest/exercise echocardiography
* AE/SAE Review
* Concomitant medication review
Follow-up period (Visit 15) A follow-up visit will occur 3 weeks after the last dose of the study medication.
Visit 15:
* Physical examination
* 12-lead ECG
* Vital signs
* WHO FC assessment
* Pregnancy test
* Hematology
* NT-proBNP sample collection
* Clinical worsening assessment
* QoL assessments
* AE/SAE Review
* Concomitant medication review
Following the last dose of study drug administration, participants have the option to continue with open label sotatercept supplied directly from the manufacturer until either the participant discontinues sotatercept or reimbursement through public or private insurance is in place. The treating physician will be responsible for ongoing monitoring and administration of sotatercept beyond the last dose.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sotatercept Group Sotatercept Sotatercept 0.7mg/kg
- Primary Outcome Measures
Name Time Method Lung diffusing capacity 23 weeks post starting treatment Lung diffusing capacity (DLCO) will be measured using six-second, advanced DLCO techniques
Pulmonary capillary blood volume (Vc) 23 weeks post starting treatment Pulmonary capillary blood volume (Vc) will be measured using six-second, advanced DLCO techniques
Diffusing membrane capacity (Dm) 23 weeks post starting treatment Diffusing membrane capacity will be measured using six-second, advanced DLCO
- Secondary Outcome Measures
Name Time Method Peripheral muscle microcirculation 23 weeks post starting treatment Peripheral muscle microcirculation will be measured using continuous-wave near-infrared spectroscopy
Cardiac structure and function 23 weeks post starting treatment Cardiac structure will be measured using standard cardiac ultrasound
Cardiac function 23 weeks post starting treatment Cardiac function will be measured using standard cardiac ultrasound