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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
David Ptashnik, MS
david.ptashnik@duke.edu
919-668-2642
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 20
Treatments
Other: Idiopathic Pulmonary Arterial Hypertension
Arm 1... patients with IPAH
Other: Pulmonary Arterial Hypertension Associated with Connective Tissue Disease
Arm 2... patients with CTD-PAH
Related Therapeutic Areas
Sponsors
Leads: Bastiaan Driehuys
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov

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