CompletedPhase 2

Impact of Evolocumab in Cardiac Transplant Patients With CAV

United States26 participantsStarted 2019-07-15

Plain-language 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.

Who can participate

Age range19 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent Change in Serum LDL (mg/dL) After 12 Weeks of Evolocumab

Timeframe: 12 weeks

Trial details

NCT IDNCT03944577

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-28

Results submitted2024-03-28

View on ClinicalTrials.gov More Heart Transplant trials