Xenon MRI in Stable Pulmonary Hypertension (Jupiter AUGEAN)

NCT06122922 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Pro00113235
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pulmonary Artery Hypertension

Outcome Measures

Primary Outcomes (3)

• Change in pulmonary vascular function

  Measured by RBC/Membrane metrics on Xe MRI

  Baseline, 3 months, 6 months, 1 year

• Change in pulmonary vascular function

  Measured by RBC shift metrics on Xe MRI

  Baseline, 3 months, 6 months, 1 year

• Change in pulmonary vascular functoin

  Measured by RBC amplitude oscillation metrics on Xe MRI

  Baseline, 3 months, 6 months, 1 year

Secondary Outcomes (4)

• Six Minute Walk Test Distance (6MWD)

  Baseline, 3 months, 6 months, 1 year

• NTproBNP

  Baseline, 3 months, 6 months, 1 year

• World Health Organization (WHO) Functional Class (FC)

  Baseline, 3 months, 6 months, 1 year

• Hopsitalizations

  Baseline, 3 months, 6 months, 1 year

Study Arms (1)

Patients with Stable Pulmonary Arterial Hypertension

OTHER

Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months Intervention: Drug: 129Xe Hyperpolarized

Drug: Hyperpolarized Xe129

Interventions

Hyperpolarized Xe129 DRUG

Hyperpolarized Xenon Gas

Patients with Stable Pulmonary Arterial Hypertension

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable on current treatment regimen and not planning to undergo initiation of new therapy for at least 3 months
• Outpatients of any gender, Age 18-75
• WHO functional class (FC) 1-3 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

You may not qualify if:

• Sarcoidosis
• Active cancer
• Sickle cell anemia
• Liver disease (Childs-Pugh class C)
• Any conditions that prevent the performance of 129Xe MRI scans.
• Prisoners and pregnant women will not be approached for the study
• 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

Sponsors & Collaborators

• Bastiaan Driehuys: lead
• Regeneron Pharmaceuticals: collaborator

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sudarshan Rajagopal, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: IND Holder

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: March 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share