RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Sotatercept for Pulmonary Artery Hypertension

The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. you would be asked to: * Take Sotatercept every 21 days (±3 days) * Each you would 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.

Official registry: https://clinicaltrials.gov/study/NCT07140484 · University of Alberta · enrollment listed as 27

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Sotatercept. The registry lists allocation as na. The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.

They plan to enroll about 27 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)

Interventions: Sotatercept

Primary outcome (registry wording): Lung diffusing capacity

Who it is for (from inclusion criteria)

Ages 18 Years to any
Eligible participants must meet all of the following to be enrolled in the study:
Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:
Drug/toxin-induced PAH
PAH associated with CTD
PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
Symptomatic PAH classified as WHO FC II or III
Females of childbearing potential must:

Who the registry excludes

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
Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test
Baseline platelet count \< 50,000/mm3 (\< 50.0 × 109/L) in the enrollment period
Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \> 160 mmHg or sitting diastolic blood pressure \> 100 mmHg during a screening visit after a period of rest

Public study contact (from the registry)

Desi Fuhr, MSc

7804921121

fuhr@ualberta.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Clinical Physiology Laboratory — Edmonton, Alberta, Canada (recruiting)

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FAQ about this NCT record

Is NCT07140484 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07140484?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07140484?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary