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NCT04991454RecruitingPhase 2

Xenon MRI Pulm Hypertension

Xenon MRI in Pulmonary Hypertension

Source: ClinicalTrials.gov · Last updated 10 Aug 2026

Brief summary (registry, in English)

The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
7 Jul 2021
Start date
1 Sept 2021
Primary completion date
31 Jul 2027
Lead sponsor
Bastiaan Driehuys
NCT number
NCT04991454

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From 1 Sept 2021 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
  • 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
  • Active cancer
  • Liver disease (Childs-Pugh class C)
  • Any conditions that prevent the performance of 129Xe MRI scans.
  • 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%, Severe LV hypertrophy, Moderate to severe valvular disease)

Other

  • Subjects presenting with any of the following will not be included in the trials:
  • PH due to schistosomiasis
  • Sickle cell anemia
  • Prisoners and pregnant women will not be approached for the study
  • Subjects presenting with any of the following will not be included in the trials:
  • Sarcoidosis
  • Sickle cell anemia
  • Prisoners and pregnant women will not be approached for the study.

Who the study is looking for

  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
  • Outpatients of either gender, Age 18-75
  • Awaiting a lung transplant
  • Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, pulmonary vascular resistance ≥ 3 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH), 3 (PH due to chronic lung disease, 4 (PH due to pulmonary artery obstructions), or 5 (PH due to miscellaneous causes)
  • Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
  • Women of childbearing potential must have a negative urine pregnancy test before MRI
  • Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
  • Treatment naïve or treatment started within the last 3 months
  • Outpatients of either gender, Age 18-75
  • WHO functional class (FC) 2-3 symptoms with a diagnosis of group 1 PH (mean pulmonary artery pressures (mPAP) \> 20 mmHg, pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg and pulmonary vascular resistance (PVR) ≥3 WU)
  • Willing and able to give informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
  • Women of childbearing potential must have a negative urine pregnancy test before MRI

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.