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Pulmonary Hypertension SOLAR (PH SOLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04778046
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Bastiaan Driehuys, Duke University

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.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease COPD Pulmonary Arterial Hypertension Drug: Hyperpolarized 129Xe Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
Estimated Study Start Date : December 15, 2022
Estimated Primary Completion Date : August 30, 2023
Estimated Study Completion Date : August 30, 2023


Arm Intervention/treatment
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.
Drug: Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Other Name: Xe MRI

Experimental: COPD-noPH
Clinical diagnosis of COPD in the absence of precapillary PH.
Drug: Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Other Name: Xe MRI

Experimental: COPD-PH
Clinical diagnosis of COPD with precapillary PH
Drug: Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Other Name: Xe MRI

Experimental: IPF-noPH
Clinical diagnosis of IPF in the absence of precapillary PH
Drug: Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Other Name: Xe MRI

Experimental: IPF-PH
Clinical diagnosis of IPF with precapillary PH
Drug: Hyperpolarized 129Xe
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Other Name: Xe MRI




Primary Outcome Measures :
  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 [ Time Frame: 2 yrs ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778046


Contacts
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Contact: David Ptashnik, MS 919-668-2642 david.ptashnik@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: David Ptashnik, MS    919-668-2642    david.ptashnik@duke.edu   
Principal Investigator: Sudarshan Rajagopal, MD, PhD         
Sponsors and Collaborators
Bastiaan Driehuys
Investigators
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Principal Investigator: Sudarshan Rajagopal, MD, PhD Duke University
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Responsible Party: Bastiaan Driehuys, Associate Professor of Radiology, Duke University
ClinicalTrials.gov Identifier: NCT04778046    
Other Study ID Numbers: Pro00106221
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bastiaan Driehuys, Duke University:
Lung Transplant
Group 3 PH
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Arterial Hypertension
Lung Diseases, Interstitial
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Hypertension, Pulmonary