Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04778046

Pulmonary Hypertension SOLAR

Led by Bastiaan Driehuys · Updated on 2026-02-24

30

Participants Needed

1

Research Sites

246 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pulmonary Hypertension SOLAR

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Currently on the lung transplant waiting list at Duke University Medical Center
  • Pulmonary hypertension confirmed by right heart catheterization with mean pulmonary artery pressure over 20 mmHg, pulmonary vascular resistance over 3 Wood units, and pulmonary capillary wedge pressure under 15 mmHg
  • Diagnosed with one of the following groups: PAH without severe lung disease or other excluded conditions; COPD without PH; COPD with PH; IPF without PH; IPF with PH
  • Willing and able to give informed consent and follow study visit and protocol schedules
Not Eligible

You will not qualify if you...

  • Moderate to severe heart disease including left ventricular ejection fraction less than 45% or severe left ventricular hypertrophy
  • Sarcoidosis
  • Active cancer
  • Sickle cell anemia
  • Liver disease classified as Child-Pugh class C
  • Prisoner or pregnant
  • Unable to provide consent
  • Conditions preventing MRI scanning such as metal in the eye, claustrophobia, or inability to lie flat
  • Medical or psychological conditions that may pose undue risk or interfere with protocol compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

C

Claudia Salazar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

5

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