Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension (NCT05339386) | Clinical Trial Compass
CompletedNot Applicable
Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension
United States10 participantsStarted 2022-08-29
Plain-language summary
In this study, hyperpolarized 129Xe MRI will be used to evaluate treatment efficacy in patients with pulmonary arterial hypertension (PAH). Participants will be imaged at 4 timepoints (baseline, 6 weeks post-therapy initiation, 12 weeks, and 18 weeks). Images will be analyzed to develop new biomarkers and to understand treatment effects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years of age
* Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
* Idiopathic PAH
* Heritable PAH
* Drug/toxin-induced PAH
* PAH associated with CTD
* Symptomatic PAH classified as WHO FC I, II, or III.
* Documented Historical RHC with a mPAP ≥ 20 mmHg, PCWP ≤15 mmHg, and PVR ≥ 3 Wood Units (WU)
* Ability to adhere to the study visit schedule, adhere, and comply with all protocol requirements.
* Ability to understand and provide written informed consent.
For patients in the Initiating Therapy Arm:
* Initiation of pulmonary vasodilator therapy within ±3 weeks of baseline imaging timepoint.
For patients in the Stable Arm:
* On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice
Exclusion Criteria:
* Subject unable to undergo MRI based on MRI safety screening
* Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
* Pregnant or breastfeeding female subjects
* Prisoners or incarcerated individuals
* Any major surgical procedure within 90 days prior to study enrollment or planned surgical procedure during the study period.
* Concomitant medical disorder, condition, or history, that in the opinion of the I…