Recruiting
Phase 2

Pulmonary Hypertension

Sponsor:

Bastiaan Driehuys

Code:

NCT04778046

Conditions

Interstitial Lung Disease

COPD

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 129Xe

Study Details

Brief summary:

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

Interstitial Lung Disease

COPD

Pulmonary Arterial Hypertension

Study ID

NCT04778046

Start date

Nov 8, 2023

Status verified date

Feb, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 18 years' old
2. Be on the lung transplant waiting list at Duke University Medical Center.
3. PH as defined by RHC - mPAP > 20 mmHg, PVR > 3 WU, PCWP < 15 mmHg
4. Groups defined as:

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.

COPD-noPH: Clinical diagnosis of COPD in the absence of precapillary PH.

COPD-PH: Clinical diagnosis of COPD with precapillary PH.

IPF-noPH: Clinical diagnosis of IPF in the absence of precapillary PH.

IPF-PH: Clinical diagnosis of IPF with precapillary PH.
5. Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

Exclusion Criteria:

1. Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy).
2. Sarcoidosis.
3. Active cancer.
4. Sickle cell anemia.
5. Liver disease (Childs-Pugh class C).
6. Prisoners and pregnant women will not be approached for the study.
7. Inability to obtain consent.
8. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
9. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Hyperpolarized 129Xe

Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),

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 and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Sudarshan Rajagopal, MD, PhD

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

  • Lung Transplant
  • Group 3 PH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2026-02-24.