Actively Recruiting
129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
Led by Bastiaan Driehuys · Updated on 2026-02-24
20
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
B
Bastiaan Driehuys
Lead Sponsor
A
American Heart Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying pulmonary arterial hypertension (PAH), including its common subtypes idiopathic PAH (IPAH) and connective tissue disease-associated PAH (PAH-CTD). The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance (6MWD) are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups: 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.
CONDITIONS
Brief Title
129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of idiopathic pulmonary arterial hypertension or pulmonary arterial hypertension associated with connective tissue disease
- WHO functional class 2 or 3
- Mean pulmonary artery pressure greater than 20 mmHg
- Pulmonary capillary wedge pressure 15 mmHg or less
- Pulmonary vascular resistance greater than 2 Wood Units
- No other cause identified for idiopathic PAH (Arm 1)
- Diagnosis of connective tissue disease (Arm 2)
You will not qualify if you...
- Pulmonary hypertension other than idiopathic PAH or PAH associated with connective tissue disease
- Any condition that prevents the performance of 129Xe MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants undergo 129Xe MRI/MRS scans and standard of care assessments to evaluate pulmonary arterial hypertension status.
4 visits (at baseline, 3 months, 6 months, and 12 months)
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Claudia Salazar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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