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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lars Gullestad
• Collaborators: Aarhus University Hospital; Helsinki University Central Hospital; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; Skane University Hospital
• Treatments: Antibodies, Monoclonal; Evolocumab

Criteria

Inclusion Criteria:

Patients will be screened for eligibility during routine follow-up 4 - 8 weeks after heart transplantation. All of the following conditions must apply prior to administering the investigational medicinal product:

• Heart transplant recipient within the last 4 - 8 weeks.

• Age between 18 and 70 years.

• Informed consent obtained and documented according to Good Clinical Practice (GCP), and national/regional regulations.

• No contraindications to coronary angiography with intravascular ultrasound

• Estimated glomerular filtration rate > 20 ml/min/1.73 m2 as assessed by the MDRD formula.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

• Decompensated liver disease (Child-Pugh class C)

• Severe renal failure, i.e. eGFR < 20 ml/min/1.73 m2 or on renal replacement therapy

• Ongoing rejections or infections

• Known sensitivity or intolerance to evolocumab or any of the excipients of Repatha®

• Prior use of PCSK9 inhibition treatment

• Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake

• Participation in another clinical trial involving an investigational drug and/or follow-up within 30 days prior to enrolment.

• Pregnancy.

• Female subject who has either (1) not used at least one highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilised or postmenopausal.