Recruiting
Phase 2

Sotatercept

Sponsor:

Bastiaan Driehuys

Code:

NCT06351345

Conditions

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

129Xe Hyperpolarized

Study Details

Brief summary:

Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH).

Conditions

Pulmonary Hypertension

Pulmonary Arterial Hypertension

Study ID

NCT06351345

Start date

Oct 27, 2025

Status verified date

Feb, 2026

Completion date

Feb 4, 2030

Anticipated

Primary completion date

Feb 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Outpatients of either gender, Age 18-75
2. Diagnosis of precapillary PH (right heart catheterization demonstrating hemodynamic criteria of a mean pulmonary artery pressure (mPAP) ≥ 20 mmHg, pulmonary vascular resistance ≥ 5 WU, pulmonary capillary wedge pressure ≤ 15 mmHg) in the setting of Group 1 (PAH)
3. Willing and giving informed consent and adhere to visit/protocol schedules (consent must be given before any study procedures are performed).
4. On a stable dose of background PAH therapy for > 90 days prior to study enrollment
5. Women of childbearing potential must have a negative urine pregnancy test before MRI

Exclusion Criteria:

1. Moderate to severe heart disease (LVEF < 45%, Severe LV hypertrophy, Moderate to severe valvular disease)
2. Chronic thromboembolic disease
3. PH due to schistosomiasis
4. Active cancer
5. Sickle cell anemia
6. Prisoners and pregnant women will not be approached for the study
7. Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
8. Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Pulmonary Arterial Hypertension Patients Receving Sotatercept

PAH patients receiving sotatercept as treatment for their PAH

Interventions

129Xe Hyperpolarized

Each xenon dose will be limited to a volume less than 25% of participant lung capacity (TLC).

Primary outcome measure

  • Change in Xenon MRI Red Blood Cell (RBC) percentage [ Time Frame: baseline, 3,and 12 months ]
  • Change in cardiogenic oscillation amplitudes [ Time Frame: baseline, 3, and 12 months ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Sudarshan Rajagopal, MD, PhD

More Information

Sponsor

Bastiaan Driehuys

Last update posted

Feb 24, 2026

Last verified

Feb, 2026

Keywords

  • Xenon
  • MRI

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.