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RecruitingPhase 2

129 Xenon MRI as a Biomarker for Diagnosis and Response to Therapy in Pulmonary Arterial Hypertension (PAH)

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 to 75 Years
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 overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD)."
  • "Subjects in both arms of the trial will undergo a 129Xe MRI/MRS at timepoints of baseline, 3 months, 6 months, and 12 months."
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 tests whether xenon-129 MRI scans can tell apart types of pulmonary arterial hypertension (PAH), or high blood pressure in the lung arteries. It also tests whether these scans can track changes in PAH and response to treatment. It is for adults with PAH that has no known cause or is linked to connective tissue disease.

The overall study objectives outlined in this study are to derive 129Xe MRI pulmonary vascular biomarker signatures that differentiate common subtypes of PAH and to determine the ability of 129Xe MRI to longitudinally monitor disease progression and response to therapy in PAH, with the aid of additional assessments, such as labs, echocardiography, and six-minute walk distance (6MWD).

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

Eligibility

Who can join

  • Be 18 to 75 years old.
  • Have PAH with no known cause, or PAH linked to connective tissue disease, which affects tissues that support the body.
  • Have WHO functional class 2 or 3: PAH symptoms that somewhat or greatly limit physical activity.
  • Have average pressure in the lung arteries above 20 mmHg.
  • Have pulmonary capillary wedge pressure of 15 mmHg or less. This measures pressure related to the left side of the heart.
  • Have pulmonary vascular resistance above 2 Wood units. This measures how hard it is for blood to flow through the lungs.

Who can't join

  • Have a type of high blood pressure in the lungs other than PAH with no known cause or PAH linked to connective tissue disease.
  • Have any condition that prevents you from having xenon-129 MRI scans.

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

Official eligibility criteria

Inclusion Criteria: Arm 1 -IPAH * Age: 18-75 years * WHO functional class 2 or 3 * Mean pulmonary artery pressures \> 20 mmHg * Pulmonary capillary wedge pressure ≤15 mmHg * Pulmonary vascular resistance \> 2 Wood Units (WU) * No other cause identified for PAH Arm 2 -PAH-CTD * Age: 18-75 years * WHO functional class (FC) 2 or 3 * Mean pulmonary artery pressures \> 20 mmHg * Pulmonary capillary wedge pressure ≤15 mmHg * Pulmonary vascular resistance \> 2 WU * Diagnosis of connective tissue disease Exclusion Criteria: * PH other than Idiopathic PAH or PAH associated with CTD; any conditions that prevent the performance of 129Xe MRI scans will be excluded from the study.

Study sites (1)

NC