Impact of Evolocumab in Cardiac Transplant Patients With CAV

Status Completed

Clinical Trial Summary

Coronary allograft vasculopathy (CAV) is diffusely accelerated atherosclerosis of a transplanted heart. Evolocumab (Repatha) is an FDA-approved drug for lowering low density lipoprotein (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.

Clinical Trial Description

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 low density lipoprotein (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. ;

Study Design

Related Conditions & MeSH terms

Heart Transplant

Clinical Trial Details

NCT number	NCT03944577
Study type	Interventional
Source	University of Nebraska
Contact
Status	Completed
Phase	Phase 2
Start date	July 15, 2019
Completion date	March 28, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02964026` - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients	N/A
Active, not recruiting	`NCT05096299` - OCS Heart EXPAND + CAP Continued Follow-Up
Completed	`NCT02323321` - International EXPAND Heart Pivotal Trial	N/A
Not yet recruiting	`NCT05025774` - Fitness and Lung Function Among Survivors of Heart Transplant, Leukemia and Infant BPD Through Exercise
Recruiting	`NCT05933083` - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation	N/A
Completed	`NCT03150095` - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates	N/A
Active, not recruiting	`NCT02554578` - Impact of mHealth in Heart Transplant Management	N/A
Terminated	`NCT03346278` - Text Message Intervention to Improve Cardiac Rehab Participation	N/A
Active, not recruiting	`NCT05741723` - OCS DCD Heart + CAP Continued Follow-Up
Completed	`NCT03831048` - Donors After Circulatory Death Heart Trial	N/A
Completed	`NCT04615182` - Donor After Circulatory Death Heart CAP Trial	N/A
Completed	`NCT02597543` - Stress Cardiac MRI for Evaluation of Nonspecific Allograft Dysfunction	Phase 4
Recruiting	`NCT05824364` - Exercise aNd hEArt Transplant	N/A
Enrolling by invitation	`NCT05390411` - Seeking Objectivity in Allocation of Advanced Heart Failure (SOCIAL HF) Therapies Trial	N/A
Recruiting	`NCT04770012` - AERIAL Trial: Antiplatelet Therapy in Heart Transplantation	Phase 3
Terminated	`NCT01769443` - Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation	Phase 2
Completed	`NCT00466804` - Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients	N/A
Recruiting	`NCT06426173` - Effect of Resistance Training in Patients on the Waiting List for Heart Transplant	N/A
Not yet recruiting	`NCT05459181` - HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)	N/A
Terminated	`NCT01485757` - Prospective L-arginine Study	Phase 1