Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The main goal of this study is to evaluate the effect of the proprotein convertase
subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab on cardiac allograft vasculopathy in de
novo heart transplant recipients.
Secondary objectives are to assess the impact of treatment on: i) cholesterol levels, ii)
renal function, iii) inflammation, iv) quality of life, v) cardiac function as assessed by
biomarkers and echocardiography, vi) the number of rejections, and (vii) safety and
tolerability. As an exploratory outcome, the investigators will asses the effect of treatment
on clinical events (death, myocardial infarction, cerebral stroke, cancer, end stage renal
disease).
Phase:
Phase 3
Details
Lead Sponsor:
Lars Gullestad
Collaborators:
Aarhus University Hospital Helsinki University Central Hospital Rigshospitalet, Denmark Sahlgrenska University Hospital, Sweden Skane University Hospital