Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients

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).

Conditions

• Cardiac Allograft Vasculopathy

Interventions

DRUG

Evolocumab

420 mg evolocumab will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.

DRUG

Placebo

Placebo will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Lars Gullestad

  lead OTHER

Principal Investigators

• Lars Gullestad, MD, PhD · Oslo University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-10

Primary Completion

2023-05-20

Completion

2023-05-20

Countries

• Denmark
• Finland
• Sweden

Study Locations