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Completed

NCT Number: NCT06907693

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

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).

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT Pulmonary Angiography Scan

Diagnostic Test

Computed tomography (CT) pulmonary angiography scan of the chest with IV contrast

Primary outcomes

  1. Ratio of BV5A to BV10A

    Time frame: From baseline CT scan to 12 month CT scan

    Change from baseline to month 12 in the ratio BV5A/BV10A

Secondary outcomes

  1. Ratio of BV5A to BV5APR

    Time frame: From baseline CT scan to 12 month CT scan

    Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APR variable.

  2. Ratio of BV5A to BV5APRA

    Time frame: From baseline CT scan to 12 month CT scan

    Change from baseline CT scan to 12 month CT scan regarding the ratio of the BV5A to BV5APRA variable.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Cereno Scientific AB

Registry information

Official study title

The Effects of Drug Candidate CS1 on Lung Structure and Function Utilizing FRI, a Non-Invasive, Functional Respiratory Imaging System

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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