Xenon MRI Pulm Hypertension

ConditionsPulmonary Hypertension Pulmonary Arterial Hypertension

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBastiaan Driehuys

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Moderate to severe heart disease (LVEF <45%, Severe LV hypertrophy, Moderate to severe valvular disease)

PH due to schistosomiasis

Active cancer

Sickle cell anemia

Trial design

Design model

Single group

Treatments tested in this trial

129Xe Hyperpolarized
Drug
Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), as is the case for all protocols currently carried out under IND 109,490.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: end-stage pulmonary hypertension .Other 1 intervention

Group B: following pulmonary arterial hypertension subjectsOther 1 intervention

Trial outcomes

Primary outcomes

pulmonary vascular remodeling

The study team will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to pathologic scoring of pulmonary vascular remodeling from histopathology is statistically significant.

Time frame

5 years

Red Blood Cell Signal from Xenon MRI

We will determine whether the correlation between Red Blood Cell Signal from Xenon MRI to six minute walk distance, tricuspid annular plane excursion and right ventricular systolic pressure in longitudinal follow-up of PAH patients is statistically significant.

Time frame

5 years

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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