The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI

Prisma Health-Upstate

Status: Active, not recruiting

Conditions: Pulmonary Arterial Hypertension

Treatments: Diagnostic Test: CT Pulmonary Angiography Scan

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06907693

2282898

Details and patient eligibility

About

Explore the impact of drug candidate CS1 on pathological vascular remodeling of small pulmonary arteries in the disease pulmonary arterial hypertension (PAH). This sub-study for CS1-004 aims to utilize FRI, an innovative, non-invasive imaging technology to visualize how long-term use of CS1 influences structural changes in pulmonary arteries. This sub-study seeks to provide valuable insights into the potential of CS1 to transform PAH treatment in some patients enrolled in the Expanded Access Program (CS1-004).

Enrollment: 7 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in the CS1-004 clinical trial

Exclusion criteria

• Inability to undergo a CT pulmonary angiography scan (i.e., claustrophobia)
• Individuals who are pregnant or who become pregnant during the sub-study
• eGFR <30 mL/min/1.73m2 as calculated by Modification of Diet in Renal Disease (MDRD)
• Allergy to Iodine contrast agents

Trial design

7 participants in 1 patient group

CT Pulmonary Angiography Recipient

Description:

All subjects in this study will undergo CT pulmonary angiography scans at baseline (+/- 2 months from start of drug therapy), 4 months and 12 months.

Treatment:

Diagnostic Test: CT Pulmonary Angiography Scan