Pulmonary Hypertension SOLAR

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Bastiaan Driehuys
Study ID
NCT04778046
Phase
PHASE2
Status
Recruiting
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Conditions

  • COPD
  • Interstitial Lung Disease
  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized 129Xe — DRUG
    Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),

Study Details

The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.

Key Dates

Start date
Nov 8, 2023
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PAH:
    Clinical diagnosis of PAH (Group 1 PH) in the absence of severe chronic lung disease, left heart disease, chronic thromboembolism, sarcoidosis, sickle cell disease or other causes of non-Group 1 PH.
  • Experimental: COPD-noPH
    Clinical diagnosis of COPD in the absence of precapillary PH.
  • Experimental: COPD-PH
    Clinical diagnosis of COPD with precapillary PH
  • Experimental: IPF-noPH
    Clinical diagnosis of IPF in the absence of precapillary PH
  • Experimental: IPF-PH
    Clinical diagnosis of IPF with precapillary PH

Primary Outcome Measure

a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
David Ptashnik, MS
[email protected]
919-668-2642
Sudarshan Rajagopal, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
COPD
By specialty
PulmonologyLung disease
By research site
Duke University Medical Center· Durham, NC

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