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

First listed
Mar 2, 2021
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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