RightFit
RecruitingPhase 2

Pulmonary Hypertension SOLAR

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses a special xenon MRI lung scan to look for changes in lung blood vessels in people with Group 3 pulmonary hypertension (PH), or high blood pressure in the lungs linked to lung disease. Researchers will compare the scans with lung tissue removed during a transplant. The study is for adults on Duke’s lung transplant waiting list with certain lung diseases or PH.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Be on the lung transplant waiting list at Duke University Medical Center.
  • The listing requires PH confirmed by a heart catheter test, which measures pressure: mPAP above 20 mmHg, PVR above 3 WU, and PCWP below 15 mmHg.
  • Have one of the listed conditions: Group 1 pulmonary arterial hypertension (PAH); COPD, a disease that makes breathing hard; or IPF, a disease that scars the lungs. The COPD and IPF groups include people with and without PH.
  • For the PAH group, have no severe long-term lung disease, left heart disease, long-term lung blood clots, sarcoidosis, sickle cell disease, or other causes of PH outside Group 1.
  • Be willing and able to give informed consent before study tests and follow the study visit schedule.

Who can't join

  • Moderate to severe heart disease, including a heart pumping measure below 45% or severe thickening of the heart’s main pumping chamber.
  • Sarcoidosis, a disease that causes patches of swelling in the body.
  • Active cancer.
  • Sickle cell anemia, an inherited red blood cell disease.
  • Severe liver disease called Child-Pugh class C.
  • Being in prison, being pregnant, or being unable to give informed consent.
  • Anything that prevents an MRI scan, such as metal in the eye, fear of tight spaces, or being unable to lie on your back.
  • A medical or mental health condition that the study doctor thinks could make the study too risky or prevent you from following study rules.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC