Xenon MRI in Pulmonary Hypertension

Who is this study for? Patients with pulmonary hypertension
What treatments are being studied? 129Xe Hyperpolarized
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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⁃ Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

• Outpatients of either gender, Age 18-75

• Awaiting a lung transplant

• Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease, 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes)

• Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

• Women of childbearing potential must have a negative urine pregnancy test before MRI

⁃ Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

• Treatment naïve or treatment started within the last 3 months

• Outpatients of either gender, Age 18-75

• WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)

• Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

• Women of childbearing potential must have a negative urine pregnancy test before MRI

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: 2021-09-01
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 60
Treatments
Other: end-stage pulmonary hypertension .
subjects with end-stage PH that currently on the waitlist for lung transplant
Other: following pulmonary arterial hypertension subjects
Following pulmonary arterial hypertension subjects upto 24 months
Related Therapeutic Areas
Sponsors
Leads: Bastiaan Driehuys

This content was sourced from clinicaltrials.gov