Recruiting
Phase 2

Xenon MRI

Sponsor:

Bastiaan Driehuys

Code:

NCT06104228

Conditions

Pulmonary Arterial Hypertension

Idiopathic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)

Connective Tissue Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

129Xe Hyperpolarized

Study Details

Brief summary:

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).

Conditions

Pulmonary Arterial Hypertension

Idiopathic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Associated With Connective Tissue Disease (Disorder)

Connective Tissue Diseases

Study ID

NCT06104228

Start date

Aug 12, 2024

Status verified date

Feb, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Idiopathic Pulmonary Arterial Hypertension

Arm 1... patients with IPAH

other: Pulmonary Arterial Hypertension Associated with Connective Tissue Disease

Arm 2... patients with CTD-PAH

Interventions

129Xe Hyperpolarized

Each xenon dose will be limited to a volume less than 25% of a subject's total lung capacity (TLC), as is the case for all protocols currently carried out under IND 109490

Primary outcome measure

  • Pulmonary Vascular Remodeling [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Claudia Salazar

+1 919 660 2026claudia.salazar@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

David Ptashnik

9196682642david.ptashnik@duke.edu

Principal Investigator:

Fawaz A Alenezi, MD

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bastiaan Driehuys on 2026-02-24.