Pulmonary Hypertension SOLAR

NCT ID: NCT04778046

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2025-12-30

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.

Detailed Description

The objective of this study is to identify a 129Xe MRI signature associated with PAH-like pulmonary vascular remodeling, consisting of plexiform arteriopathy, smooth muscle cell proliferation, and vascular fibrosis, in IPF and COPD that could be used to identify potential responders vs non-responders to PAH-specific therapies. The central hypothesis is that similar mechanisms and pathways underlie pulmonary vascular remodeling in IPF-PH, COPD-PH, and PAH. However, only a subset of Group 3 PH patients display remodeling consistent with PAH, resulting in responder vs. non-responder phenotypes when treated with PAH-specific therapies. In preliminary studies of subjects treated with Tyvaso, The study team has observed distinct 129Xe MRI signatures at baseline and with therapy depending on patients' underlying lung function. Consistent with this, recent studies using single-cell RNA sequencing (scRNAseq) of the pulmonary vasculature in IPF have demonstrated changes consistent with vascular remodeling.

Conditions

Interstitial Lung Disease; COPD; Pulmonary Arterial Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe

Intervention Type: DRUG

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

COPD-noPH

Clinical diagnosis of COPD in the absence of precapillary PH.

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe

Intervention Type: DRUG

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

COPD-PH

Clinical diagnosis of COPD with precapillary PH

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe

Intervention Type: DRUG

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

IPF-noPH

Clinical diagnosis of IPF in the absence of precapillary PH

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe

Intervention Type: DRUG

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

IPF-PH

Clinical diagnosis of IPF with precapillary PH

Group Type: EXPERIMENTAL

Hyperpolarized 129Xe

Intervention Type: DRUG

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

Interventions

Hyperpolarized 129Xe

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

Intervention Type: DRUG

Other Intervention Names

Xe MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bastiaan Driehuys

OTHER

Sponsor Role: lead

Responsible Party

Bastiaan Driehuys

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sudarshan Rajagopal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claudia Salazar

Role: CONTACT

claudia.salazar@duke.edu

+1 919 660 2026

Facility Contacts

David Ptashnik, MS

Role: primary

david.ptashnik@duke.edu

919-668-2642

Other Identifiers

Pro00106221

Identifier Type: -

Identifier Source: org_study_id