No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
30 (estimated)
Sponsor
Bastiaan Driehuys · Other
Who this trial is looking for
This trial is looking for adults who are on the lung transplant waiting list at Duke University Medical Center and have specific types of pulmonary hypertension. Participants will help develop a noninvasive imaging technique to better understand their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I am on the lung transplant waiting list at Duke University Medical Center.
I have pulmonary hypertension.
I have COPD or interstitial lung disease.
I can give informed consent and follow the study schedule.
You may not be able to join if
I have moderate to severe heart disease.
I have sarcoidosis.
I have active cancer.
I have sickle cell anemia.
I have liver disease.
I am a prisoner or pregnant.
I cannot give consent.
I have conditions preventing me from having an MRI.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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" correlat…
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.
Trial Locations
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Status
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…
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
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