Status:
ACTIVE_NOT_RECRUITING
Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Brief 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 wee...
Detailed Description
1. Optimize Xe-MRI Oscillation Imaging for PAH. Regional mapping of oscillations in the xenon RBC signal is a new technique that may provide new insights into microvascular function in PH. Recent inno...
Eligibility Criteria
Inclusion
- 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
- 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 Investigator would impair the subject's ability to participate in or complete the requirements of the study
- Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of the study
Key Trial Info
Start Date :
August 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05339386
Start Date
August 29 2022
End Date
March 31 2025
Last Update
April 2 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160