Pulmonary Hypertension SOLAR

NCT04778046 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Pro00106221
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Lung Transplant; Group 3 PH

Outcome Measures

Primary Outcomes (1)

• a pathology-based 129Xe MRI noninvasive signature of pulmonary vascular remodeling that could be validated in a larger cohort of Group 3 PH patients

  Such a signature could then be tested in clinical trials in Group 3 PH. These studies will have an important positive impact because they lay the foundation for a precision medicine strategy in Group 3 PH through the identification of potential responders and non-responders to PAH-specific therapies

  Day 1

Study Arms (5)

PAH:

EXPERIMENTAL

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.

Drug: Hyperpolarized 129Xe

COPD-noPH

EXPERIMENTAL

Clinical diagnosis of COPD in the absence of precapillary PH.

Drug: Hyperpolarized 129Xe

COPD-PH

EXPERIMENTAL

Clinical diagnosis of COPD with precapillary PH

Drug: Hyperpolarized 129Xe

IPF-noPH

EXPERIMENTAL

Clinical diagnosis of IPF in the absence of precapillary PH

Drug: Hyperpolarized 129Xe

IPF-PH

EXPERIMENTAL

Clinical diagnosis of IPF with precapillary PH

Drug: Hyperpolarized 129Xe

Interventions

Hyperpolarized 129Xe DRUG

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

Also known as: Xe MRI

COPD-PH; COPD-noPH; IPF-PH; IPF-noPH; PAH:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years' old
• Be on the lung transplant waiting list at Duke University Medical Center.
• PH as defined by RHC - mPAP \> 20 mmHg, PVR \> 3 WU, PCWP \< 15 mmHg
• 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.
• Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

You may not qualify if:

• Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy).
• Sarcoidosis.
• Active cancer.
• Sickle cell anemia.
• Liver disease (Childs-Pugh class C).
• Prisoners and pregnant women will not be approached for the study.
• Inability to obtain consent.
• Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
• 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

Sponsors & Collaborators

• Bastiaan Driehuys: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary

Study Officials

• Sudarshan Rajagopal, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Salazar

CONTACT

+1 919 660 2026; claudia.salazar@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: November 8, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)