Clinical trial

Impact of Evolocumab (Repatha) in Cardiac Transplant Patients With Coronary Allograft Vasculopathy

Name

0104-19-FB

Description

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.

Trial arms

Trial start

2019-07-15

Estimated PCD

2023-03-28

Trial end

2023-03-28

Status

Completed

Phase

Early phase I

Treatment

Evolocumab

Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.

Arms:

Evolocumab

Other names:

Repatha

Size

Primary endpoint

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

12 weeks

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}

Updated at

2024-06-03

1 organization

1 product

1 indication

Organization

University of Nebraska

Product

Evolocumab

Indication

Heart Transplant