Using alirocumab to prevent heart transplant complications

ACAV: Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients

This study is testing if a medication called alirocumab can help prevent heart transplant complications in recent heart transplant recipients by lowering their cholesterol levels.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute for Clinical and Experimental Medicine (Government)
• Drugs / interventions: alirocumab
• Locations: 1 site (Prague)
• Trial ID: NCT04193306 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of alirocumab, a lipid-lowering medication, in preventing early cardiac allograft vasculopathy (CAV) in recent heart transplant recipients. The study is designed as a double-blind, placebo-controlled, randomized trial involving 126 participants across two sites in the Czech Republic. Participants will receive either alirocumab or a placebo for 12 months, alongside standard statin therapy, with regular follow-up visits to monitor outcomes. The trial aims to determine if alirocumab can effectively reduce LDL cholesterol levels and subsequently lower the risk of CAV in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone heart transplantation 3 to 8 weeks prior and are willing to participate in the study.

Not a fit: Patients with known allergies to the study medication, severe post-transplant complications, or those with extremely high LDL cholesterol levels will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of cardiac allograft vasculopathy in heart transplant recipients, improving long-term outcomes.

How similar studies have performed: While there have been studies on lipid-lowering therapies in heart transplant patients, the specific use of alirocumab for preventing CAV is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. New cardiac transplant recipient ≥ 18 years of age willing to participate in the study.
2. Ability to understand study procedures and to comply with them for the entire length of the study.
3. Written informed consent obtained from subject or subject's legal representative.
4. Heart transplantation surgery performed 3 - 8 weeks before the baseline visit.

Exclusion Criteria:

1. Known hypersensitivity/allergy reaction to study medication.
2. Complicated post-transplant outcome with poor neurological status, multiorgan failure or graft dysfunction.
3. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
4. Lipoprotein apheresis is planned of performed.
5. Level of LDL-C ≥ 8 mmol/L at screening.
6. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
7. Participation in any other interventional study.

Known hypersensitivity/allergy to contrast agent or severe renal insufficiency (eGFR ˂ 30 mL/min/1.75 m2) exclude patient from OCT imaging only, not from the whole study.

Where this trial is running

Prague

• Institute for Clinical and Experimental Medicine — Prague, Czechia (Recruiting)

Study contacts

• Study coordinator: Vojtech Melenovsky, MD, PhD

Conditions Cardiac Allograft Vasculopathy