RecruitingPhase 2NCT06104228

129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

Sponsor

Bastiaan Driehuys

Enrollment

20 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension Connective Tissue Diseases Idiopathic Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)

Summary

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria14

Arm 1 -IPAH
Age: 18-75 years
WHO functional class 2 or 3
Mean pulmonary artery pressures \> 20 mmHg
Pulmonary capillary wedge pressure ≤15 mmHg
Pulmonary vascular resistance \> 2 Wood Units (WU)
No other cause identified for PAH
Arm 2 -PAH-CTD
Age: 18-75 years
WHO functional class (FC) 2 or 3
Mean pulmonary artery pressures \> 20 mmHg
Pulmonary capillary wedge pressure ≤15 mmHg
Pulmonary vascular resistance \> 2 WU
Diagnosis of connective tissue disease

Exclusion Criteria1

PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.

Interventions

DRUG129Xe Hyperpolarized

Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490

Locations(1)

Duke University Medical Center

Durham, North Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT06104228

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