NCT04778046RecruitingPhase 2
Pulmonary Hypertension SOLAR
Defining a Noninvasive Signature for Pulmonary Vascular Remodeling in Group 3 PH
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Feb 2021
- Start date
- 8 Nov 2023
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Bastiaan Driehuys
- NCT number
- NCT04778046
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 8 Nov 2023 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active cancer.
- Liver disease (Childs-Pugh class C).
- 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
Lab values
- Moderate to severe heart disease (LVEF \< 45% or severe LV Hypertrophy).
Other
- Sarcoidosis.
- Sickle cell anemia.
- Prisoners and pregnant women will not be approached for the study.
- Inability to obtain consent.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.