๐ฌIn plain words
What the trial is, and whether it could suit you
Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Outpatients of either gender, Age 18-75
2. Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) โฅ 20 mmHg, pulmonary vascular resistance โฅ 5 WU, pulmonary capillary wedge pressure โค 15 mmHg) in the setting of Group 1 (PAH)
3. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
4. On a stable dose of background PAH therapy for \> 90 days prior to study enrollment
5. Women of childbearing potential must have a negative urine pregnancy test before MRI
Exclusion Criteria:
1. Moderate to severe heart disease (LVEF \< 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
2. Chronic thromboembolic disease
3. PH due to schistosomiasis
4. Active cancer
5. Sickle cell anemia
6. Prisoners and pregnant women will not be approached for the study
7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
8. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements