Pulmonary Hypertension SOLAR
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 Start (Actual) 8 November 2023
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 30 December 2024
👥 Enrollment (Estimated) 30
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 February 2021
  • First Submitted that Met QC Criteria 26 February 2021
  • First Posted 2 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 July 2024
  • Last Update Posted 17 July 2024
  • Last Verified July 2024