Impact of Evolocumab in Cardiac Transplant Patients With CAV

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (repatha) is an FDA-approved drug for lowering 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: Amgen
• Treatments: Antibodies, Monoclonal; Evolocumab

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:

• 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 GFR < 20 ml/min

• Known allergy to evolocumab or its components