Status:
COMPLETED
Endothelin-1 and Cardiac Allograft Vasculopathy (CAV)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
American Heart Association
Janssen, LP
Conditions:
Cardiac Allograft Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Many patients with end-stage heart failure, a condition in which the heart fails to pump enough blood to support the body's other organs, are fortunate enough to receive a heart transplant. However, d...
Eligibility Criteria
Inclusion
- 1\) New heart transplant recipients already enrolled into a prospective cohort (parent) study
- 1a) Underwent baseline coronary angiography within the first 4 months of heart transplantation
- 1b) Have yet to complete 1-year coronary angiogram
- 2\) ≥18 years old
- 3\) Have a serum creatinine \< 2.0 mg/dL (to minimize risk of contrast-induced nephropathy)
- 4\) Able to provide informed written consent.
Exclusion
- 1\) Multi-organ transplant
- 2\) Transplant-related complications and comorbidities that preclude the ability to safely perform an invasive coronary evaluation in the cardiac catheterization laboratory
- 3\) Pregnant women due to possible fetal harm; all women of childbearing potential must have a negative pregnancy test within 1 week of starting Macitentan, and 30 days after completing the one-week course of Macitentan.
- 4\) Patients who are taking potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) as these drugs can expose one to higher levels of macitentan
- 5\) Cirrhosis or baseline liver function tests (AST/ALT) \> 3x the upper limit of normal
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05373108
Start Date
May 19 2022
End Date
February 14 2023
Last Update
March 12 2024
Active Locations (1)
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1
Ronald Regan UCLA Medical Center
Los Angeles, California, United States, 90095