Xenon MRI Pulm Hypertension

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bastiaan Driehuys
Study ID
NCT04991454
Phase
PHASE2
Status
Recruiting

Conditions

  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 129Xe Hyperpolarized — DRUG
    Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), as is the case for all protocols currently carried out under IND 109,490.

Study Details

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.

Key Dates

First listed
Aug 5, 2021
Start date
Sep 1, 2021
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

pulmonary vascular remodeling [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Claudia Salazar
919-660-2026
Sudarshan Rajagopal, MD (PRINCIPAL_INVESTIGATOR)
Bastiann Driehays, MD (SUB_INVESTIGATOR)

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