Clinical trial NCT06409026: Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
Official title: Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to see if the drug sotatercept given for 36 weeks improves the functioning of the heart and improves quality of life.


Eligibility criteria: Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* NYHA Class II-IV.
* LVEF ≥ 40 % within the preceding year.
* No recent initiation of pulmonary vasodilator in the last 60 days.
* Pulmonary arterial hypertension by right heart catheterization (Mean PA pressure ≥ 20 mmHg with PVR\>2 Wood units) with no evidence of heart failure with preserved ejection fraction (exercise PCWP \<25 mm Hg).
* Symptomatic PAH patients with plan to undergo exercise RHC for reassessment of exertional symptoms.

Exclusion Criteria

* Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.
* Planned coronary, carotid, or peripheral artery revascularization.
* Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, anemia, or more than moderate mitral or aortic heart valve disease).
* Wheelchair bound or orthopedic inability to exercise.
* Chronic hypoxemia with inability to exercise without oxygen supplementation.
* Skeletal muscle myopathy.
* History of rhabdomyolysis.
* Participation in any clinical trial of an approved or non-approved device for the treatment of pulmonary hypertension within 30 days before screening.
* Receipt of any investigational medicinal product within 30 days before screening.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
* Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

Primary outcomes:
measure: Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Oxygen Consumption (VO2)
timeFrame: Baseline, 24 weeks
measure: Single leg blood flow at peak exercise
timeFrame: Baseline, 24 weeks
measure: Pulmonary vascular resistance at rest
timeFrame: Baseline, 24 weeks
measure: Pulmonary vascular resistance at peak exercise
timeFrame: Baseline, 24 weeks
measure: Pulmonary arterial (PA) compliance at rest
timeFrame: Baseline, 24 weeks
measure: Pulmonary arterial (PA) compliance at peak exercise
timeFrame: Baseline, 24 weeks
measure: Pulmonary arterial elastance at rest
timeFrame: Baseline, 24 weeks
measure: Pulmonary arterial elastance at peak exercise
timeFrame: Baseline, 24 weeks
measure: Left ventricular (LV) transmural pressure at rest
timeFrame: Baseline, 24 weeks
measure: Left ventricular (LV) transmural pressure at peak exercise
timeFrame: Baseline, 24 weeks
measure: Right Ventricular Pulmonary Artery Coupling at rest
timeFrame: Baseline, 24 weeks
measure: Right Ventricular Pulmonary Artery Coupling at peak exercise
timeFrame: Baseline, 24 weeks
measure: Eccentricity index at rest
timeFrame: Baseline, 24 weeks
measure: Eccentricity index at peak exercise
timeFrame: Baseline, 24 weeks
measure: Right atrial pressure (RA) at rest
timeFrame: Baseline, 24 weeks
measure: Right atrial pressure (RA) at peak exercise
timeFrame: Baseline, 24 weeks
measure: Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise
timeFrame: Baseline, 24 weeks
measure: Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise
timeFrame: Baseline, 24 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogesh Reddy, MBBS
role: PRINCIPAL_INVESTIGATOR
References: