Pulmonary Hypertension SOLAR

ConditionsInterstitial Lung Disease COPD Pulmonary Arterial Hypertension

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorBastiaan Driehuys

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).

Disqualifiers

Moderate to severe heart disease (LVEF < 45% or severe LV Hypertrophy).

Sarcoidosis.

Active cancer.

Sickle cell anemia.

Trial design

Design model

Parallel

Treatments tested in this trial

Hyperpolarized 129Xe
Drug
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),

Treatment groups

30 Participants

are divided into 5 treatment groups

Group A: PAH:Experimental treatment 1 intervention

Group B: COPD-noPHExperimental treatment 1 intervention

Group C: COPD-PHExperimental treatment 1 intervention

Group D: IPF-noPHExperimental treatment 1 intervention

Group E: IPF-PHExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bastiaan Driehuys

Lead sponsor

Duke University

Sponsor institution

Source ClinicalTrials.gov

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