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Pulmonary Hypertension SOLAR (PH SOLAR)

Primary Purpose

Interstitial Lung Disease, COPD, Pulmonary Arterial Hypertension

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hyperpolarized 129Xe

About this trial

This is an interventional diagnostic trial for Interstitial Lung Disease focused on measuring Lung Transplant, Group 3 PH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

PAH:

COPD-noPH

COPD-PH

IPF-noPH

IPF-PH

Arm Description

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.

Clinical diagnosis of COPD in the absence of precapillary PH.

Clinical diagnosis of COPD with precapillary PH

Clinical diagnosis of IPF in the absence of precapillary PH

Clinical diagnosis of IPF with precapillary PH

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04778046

First Posted

February 26, 2021

Last Updated

October 20, 2023

Sponsor

Bastiaan Driehuys

1. Study Identification

Unique Protocol Identification Number

NCT04778046

Brief Title

Pulmonary Hypertension SOLAR

Acronym

PH SOLAR

Official Title

Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2023 (Anticipated)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Bastiaan Driehuys

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Lung Disease, COPD, Pulmonary Arterial Hypertension

Keywords

Lung Transplant, Group 3 PH

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PAH:

Arm Type

Experimental

Arm Description

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.

Arm Title

COPD-noPH

Arm Type

Experimental

Arm Description

Clinical diagnosis of COPD in the absence of precapillary PH.

Arm Title

COPD-PH

Arm Type

Experimental

Arm Description

Clinical diagnosis of COPD with precapillary PH

Arm Title

IPF-noPH

Arm Type

Experimental

Arm Description

Clinical diagnosis of IPF in the absence of precapillary PH

Arm Title

IPF-PH

Arm Type

Experimental

Arm Description

Clinical diagnosis of IPF with precapillary PH

Intervention Type

Drug

Intervention Name(s)

Hyperpolarized 129Xe

Other Intervention Name(s)

Xe MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 yrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Ptashnik, MS

Phone

919-668-2642

david.ptashnik@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sudarshan Rajagopal, MD, PhD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Ptashnik, MS

Phone

919-668-2642

david.ptashnik@duke.edu

First Name & Middle Initial & Last Name & Degree

Sudarshan Rajagopal, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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