Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Effect of Sotatercept on Central Cardiopulmonary Performance and Peripheral Oxygen Transport During Exercise in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409026
• Other study ID #: 24-002570
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2024
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Yogesh Reddy, MBBS
• Phone: 507-284-3687
• Email: Reddy.Yogesh[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Sotatercept
As per FDA indications, sotatercept will be administered as 0.3 mg/kg injection for the first dose followed by 0.7 mg/kg injections for subsequent doses.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary arterial mean pressure/Cardiac Output (PA/CO) at peak exercise	Peak exercise pulmonary arterial mean pressure/ Cardiac output (mm Hg/L/min)	Baseline, Week 24
Secondary	Oxygen Consumption (VO2)	VO2 will be measured in mL/kg/min. It will be directly measured using expired gas analysis.	Baseline, 24 weeks
Secondary	Single leg blood flow at peak exercise	Single leg blood flow will be obtained from venous access. Single leg blood flow will be measured in ml/min	Baseline, 24 weeks
Secondary	Pulmonary vascular resistance at rest	Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)	Baseline, 24 weeks
Secondary	Pulmonary vascular resistance at peak exercise	Pulmonary vascular resistance will be measured in Wood units (mmHg/L/min)	Baseline, 24 weeks
Secondary	Pulmonary arterial (PA) compliance at rest	PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.	Baseline, 24 weeks
Secondary	Pulmonary arterial (PA) compliance at peak exercise	PA compliance measures pulmonary arterial distensibility and will be recorded at Baseline and 24 Weeks. PA compliance will be measured in ml/mm Hg.	Baseline, 24 weeks
Secondary	Pulmonary arterial elastance at rest	PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)	Baseline, 24 weeks
Secondary	Pulmonary arterial elastance at peak exercise	PA elastance measures pulmonary artery stiffness and will be recorded at baseline and 24 weeks as PA systolic pressure/stroke volume (units mm Hg/ml)	Baseline, 24 weeks
Secondary	Left ventricular (LV) transmural pressure at rest	LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure	Baseline, 24 weeks
Secondary	Left ventricular (LV) transmural pressure at peak exercise	LV transmural pressure will measured by catheterization at Baseline and 24 Weeks as the difference between pulmonary capillary wedge pressure and right atrial pressure	Baseline, 24 weeks
Secondary	Right Ventricular Pulmonary Artery Coupling at rest	Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)	Baseline, 24 weeks
Secondary	Right Ventricular Pulmonary Artery Coupling at peak exercise	Calculated as the ratio of RV function by echocardiography indexed to PA systolic pressure (unit mmHg-1)	Baseline, 24 weeks
Secondary	Eccentricity index at rest	Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram	Baseline, 24 weeks
Secondary	Eccentricity index at peak exercise	Eccentricity index will be calculated as the ratio of antero posterior and septolateral dimension of the left ventricle by echocardiogram	Baseline, 24 weeks
Secondary	Right atrial pressure (RA) at rest	RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks	Baseline, 24 weeks
Secondary	Right atrial pressure (RA) at peak exercise	RA pressure (mm Hg) will be measured by catheterization conducted at Baseline and 24 weeks	Baseline, 24 weeks
Secondary	Change in skeletal muscle O2 diffusive conductance (Dm) during peak exercise	Dm is measured in ml/mm Hg/min during peak exercise	Baseline, 24 weeks
Secondary	Change in skeletal muscle O2 diffusive conductance (Dm) during single leg exercise	Dm is measured in ml/mm Hg/min during single leg exercise	Baseline, 24 weeks

External Links

•   Mayo Clinic Clinical Trials