Phase 2
N=26
Impact of Evolocumab in Cardiac Transplant Patients With CAV
Heart Transplant
Bottom Line
View on ClinicalTrials.gov: NCT03944577 ↗Enrolled (actual)
26
Serious AEs
42.3%
Results posted
Jun 2024
Primary outcome: Primary: Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab — 68 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Evolocumab (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab |
68 | — |
Summary
Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (LDL) in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline.
Eligibility Criteria
Inclusion Criteria
- Heart transplant patients 19-80 years of age
- Coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac catheterization
- Able to provide signed informed consent
Exclusion Criteria
- Cardiac allograft vasculopathy (CAV) grade 3
- Rejection requiring IV therapy in the prior 3 months
- Infection requiring IV therapy in the prior 3 months
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Current or recent use of a PCSK9 inhibitor within the past 12 weeks
- Organ transplant recipient other than heart
- Renal dysfunction defined as glomerular filtration rate (GFR) < 20 ml/min
- Known allergy to evolocumab or its components
Data sourced from ClinicalTrials.gov (NCT03944577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.