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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03944577
Recruitment Status Recruiting
First Posted May 9, 2019
Last update posted July 29, 2019
Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (repatha) is an FDA-approved drug for lowering LDL in patients who have not received a heart transplant. This drug works as a PCSK9-inhibitor. The primary objective of this study is to measure the impact of PCSK9-inhibitors on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline.
Heart transplant remains the treatment of choice for patients with advanced heart failure. Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of the donor heart, and limits long term survival after transplant. The pathophysiology of CAV is complex and involves smooth muscle proliferation, inflammatory infiltrates, and lipid deposition. To date, only statin therapy has reduced CAV-related mortality. PCSK9 inhibitors are a new lipid lowering therapy shown to reduce cardiovascular clinical events in patients with coronary artery disease. We hypothesize that PCSK9 inhibition via evolocumab will significantly lower LDL and be well-tolerated in transplant patients with CAV. This phase II, open label, single center trial with enroll up to 40 heart transplant patients with CAV for treatment with evolocumab for one year. The primary outcome will be percent change in LDL at 12 weeks. Secondary outcomes will include change in CAV progression, impact of evolocumab on immunosuppression regimens and transplant rejection, and change in serum lipids after 52 weeks. Results of this study are intended to provide safety data in heart transplant patients with CAV and assess secondary outcomes including CAV progression and impact on immunosuppression and transplant rejection.
|Experimental: Treatment Arm
Patients who will receive the study drug.
Drug: Evolocumab (Repatha)
Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Heart transplant patients 19-80 years of age
- Coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac
- Able to provide signed informed consent
- CAV grade 3
- Rejection requiring IV therapy in the prior 3 months
- Infection requiring IV therapy in the prior 3 months
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal
- Current or recent use of a PCSK9 inhibitor within the past 12 weeks
- Organ transplant recipient other than heart
- Renal dysfunction defined as GFR < 20 ml/min - Known allergy to evolocumab or its components
United States, Nebraska
University of Nebraska Medical Center
University of Nebraska