Overview

Assessing Response to Inhaled Prostacyclin With Hyperpolarized Xe MRI

Status:
Recruiting

Trial end date:
2022-02-01

Target enrollment:
0

Participant gender:
All

Summary

This study seeks to deploy several forms of 129Xe MRI contrast as well as emerging conventional proton MRI techniques for imaging lung structure and perfusion. Specifically, the 129Xe MRI scans will provide 3D images of ventilation and gas exchange, and spectroscopic indices will be evaluated too test gas exchange dynamics with high temporal resolution. The conventional 1H MRi scans will include a free-breathing ultra-short echo time scan that provides images similar to that of a CT scan. This will be done pre, immediately post, and 2-4 hours post inhaled prostacyclin therapy.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bastiaan Driehuys

Collaborator:

United Therapeutics

Treatments:

Epoprostenol
Tezosentan
Xenon

Criteria

Inclusion Criteria:

Patients with known Pulmonary Hypertension on treatment with inhaled prostacyclin (iTRE)
that are followed in the Duke Pulmonary Vascular Disease Clinic. Inclusion criteria
includes: Group 1 PH (mPAP ≥ 25 mmHg, PCWP ≤ 15 mmHg in the absence of significant
concomitant left heart disease or lung disease), out-of-proportion Group 3 PH (mPAP ≥ 25
mmHg, PCWP ≤ 15 mmHg with PVR ≥ 5 WU and evidence of right heart failure in the setting of
lung disease), maintenance on a stable, well-tolerated treatment dose of iTRE (ideally ≥ 8
breaths QID). Pregnant women will be excluded from this study. Women of childbearing
potential must have a negative urine pregnancy test in order to participate on this study.

Exclusion Criteria:

-