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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Impact of Evolocumab in Cardiac Transplant Patients With CAV

Clinicaltrials.gov identifier NCT03944577

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted July 29, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Heart Transplant
  • Intervention/Treatment: Drug: Evolocumab (Repatha)
  • Phase: Phase 2
Detailed 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 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
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Impact of Evolocumab (Repatha) in Cardiac Transplant Patients With Coronary Allograft Vasculopathy
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
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.
Outcome Measures
  • Primary Outcome Measures: 1. To measure the effect of evolocumab on serum LDL as measured in mL/dL after 12 weeks of therapy in heart transplant patients. [ Time Frame: 12 weeks ]
    The primary objective of this study is to measure in the impact of PCSK9 inhibition via evolocumab on serum LDL in heart transplant patients with CAV after 12 weeks compared to baseline. Change in serum LDL will serve as the primary endpoint for comparison.
Eligibility Criteria
  • Ages Eligible for Study: 19 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Heart transplant patients 19-80 years of age

- Coronary allograft vasculopathy grade 1 or 2 documented by left heart cardiac
catheterization

- Able to provide signed informed consent

Exclusion Criteria:

- 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

Contacts and Locations
Contacts
Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha

Sponsors and Collaborators

University of Nebraska

Amgen

More Information
  • Responsible Party: University of Nebraska
  • ClinicalTrials.gov Identifier: NCT03944577 History of Changes
  • Other Study ID Numbers: 20177584
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: July 29, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: There is not a plan to make individual participant data (IPD) available) to other researchers.
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by University of Nebraska: coronary allograft vasculopathy
    heart transplant
    lipid