Phase 2 Completed N=26 Treatment

Impact of Evolocumab in Cardiac Transplant Patients With CAV

Heart Transplant

Source: ClinicalTrials.gov NCT03944577 ↗

Enrolled (actual)

Serious AEs

42.3%

Results posted

Jun 2024

Primary outcomePrimary: Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab — 68 percent change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab	68	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.