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

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Dec 6, 2019

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ClinConnect Summary

The clinical trial titled "Efficacy and Safety Of Alirocumab to Prevent Early Cardiac Allograft Vasculopathy in Recent Heart Transplant Recipients" is studying a medication called alirocumab to see if it can help heart transplant patients by lowering their cholesterol levels and preventing a condition known as cardiac allograft vasculopathy (CAV). CAV is a serious condition that can affect heart transplant recipients, leading to complications over time. The trial aims to find out if alirocumab, when used alongside standard cholesterol-lowering medication, can improve heart health in patients during the first year after their transplant.

To participate in this study, you must be at least 18 years old, have received a heart transplant within the last 3 to 8 weeks, and be willing to follow the study's requirements. Participants will receive either alirocumab or a placebo (a treatment that looks the same but has no active medication) and will be monitored for how well the medication works and its safety. Throughout the trial, doctors will also check the health of your heart vessels using a special imaging technique. If you're interested in taking part, it's important to discuss it with your healthcare provider to see if you're eligible and to understand what to expect.

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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.