Developing Hyperpolarized 129Xe MRI Biomarkers for Evaluation of Pulmonary Arterial Hypertension

NCT05339386 | Completed FDA Drug

• 1 other identifier: 00148587
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, hyperpolarized 129Xe MRI will be used to evaluate treatment efficacy in patients with pulmonary arterial hypertension (PAH). Participants will be imaged at 4 timepoints (baseline, 6 weeks post-therapy initiation, 12 weeks, and 18 weeks). Images will be analyzed to develop new biomarkers and to understand treatment effects.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in RBC/Membrane Ratio

  Absolute change over 4 imaging timepoints of RBC/Membrane Ratio from xenon MRI.

  18 weeks

Secondary Outcomes (2)

• Change in Xenon RBC uptake

  18 weeks

• Change in Xenon RBC oscillation amplitude

  18 weeks

Study Arms (2)

Initiating Therapy

PAH patients who are newly initiating background therapy to treat pulmonary arterial hypertension.

Drug: Hyperpolarized Xe129

Stable

PAH patients who are stable on therapy (On stable doses of background PAH therapy and diuretics for at least 90 days prior to screening).

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 DRUG

Lung MRI using gaseous contrast agent hyperpolarized 129Xe.

Also known as: Xenon MRI, HP Xenon, 129Xe

Initiating Therapy; Stable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants to be enrolled will include individuals with diagnosed pulmonary arterial hypertension.

You may qualify if:

• Age ≥ 18 years of age
• Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes:
• Idiopathic PAH
• Heritable PAH
• Drug/toxin-induced PAH
• PAH associated with CTD
• Symptomatic PAH classified as WHO FC I, II, or III.
• Documented Historical RHC with a mPAP ≥ 20 mmHg, PCWP ≤15 mmHg, and PVR ≥ 3 Wood Units (WU)
• Ability to adhere to the study visit schedule, adhere, and comply with all protocol requirements.
• Ability to understand and provide written informed consent.
• For patients in the Initiating Therapy Arm:
• Initiation of pulmonary vasodilator therapy within ±3 weeks of baseline imaging timepoint.
• For patients in the Stable Arm:
• On stable doses of background PAH therapy and diuretics (i.e., patient-specific dose goal for each therapy already achieved) for at least 90 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of optimal dose is allowed per medical practice

You may not qualify if:

• Subject unable to undergo MRI based on MRI safety screening
• Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5
• Pregnant or breastfeeding female subjects
• Prisoners or incarcerated individuals
• Any major surgical procedure within 90 days prior to study enrollment or planned surgical procedure during the study period.
• Concomitant medical disorder, condition, or history, that in the opinion of the Investigator would impair the subject's ability to participate in or complete the requirements of the study
• Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk or would preclude obtaining voluntary consent or would confound the objectives of the study

Sponsors & Collaborators

• American Heart Association: collaborator
• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (10 mL) will be collected from participants.

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peter Niedbalski, PHD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: August 29, 2022
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)