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Clinical Trials at Gill

The UK Gill Heart & Vascular Institute Cardiology Clinical Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase 1-4 multicenter drug and device trials, investigator-initiated protocols and translational studies. Multidisciplinary collaborations within the Gill and across UK HealthCare are key to our successful patient enrollment. Avid support of the infrastructure for clinical trials as well as education of faculty, fellows and Gill staff in clinical research methodology is at the core of our continued success.

Since its inception, the Gill Heart & Vascular Institute Cardiology Clinical Research Center has been at the forefront in leading multicenter trials investigating novel devices for patent foramen ovale (PFO) closure and left atrial pressure monitoring to treat heart failure as well as novel drug therapy for acute coronary syndrome (ACS), post-stent (post PCI) treatment, and atrial fibrillation.

The Gill offers innovative, leading-edge cardiac care including stem cell regenerative medicine for advanced heart failure, novel lipid lowering therapy and the latest catheter-based interventions.

  • Currently enrolling clinical trials

    • BIO-AffectDX
    • EMPACT-MI
    • LEADLESS II Electrophysiology
    • OPTIMIZER Electrophysiology
    • REVERSE-IT General Cardiology
    • MK-5475-007

    OPTIMIZER SMART POST-APPROVAL STUDY

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To evaluates data such as cardiac outcomes, quality of life, mortality, and functionality. Long term data are also needed to assess complication rates and potential interactions with other implantable devices in the intended patient population. The post-approval study (PAS) protocol has been designed to address these concerns in a real-world setting.


    BIO-AffectDX- Atrial Fibrillation associated with Heart Failure treated by BIOTRONIK’s CRT-DX System

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To evaluate the percent of all subjects with improvement from baseline in heart failure patients with paroxysmal, persistent, and long-standing persistent AF subtypes implanted with a two-lead BIOTRONIK CRT-DX system.


    LEADLESS-II

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To confirm the safety and effectiveness of the Aveir device from implant through 6-weeks in a subject population indicated for a VVI(R) pacemaker.


    EMPACT-MI

    PI: John Kotter, MD

    Coordinator: Stephanie Morris 859-323-5366

    Objective: To demonstrate the superiority of empagliflozin 10 mg once daily versus placebo, in addition to standard of care, for the reduction of the composite endpoint of time to first heart failure hospitalization or all-cause mortality in high-risk patients hospitalized for acute MI.


    REVERSE-IT: A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure

    PI: John Kotter, MD

    Coordinator: Jennifer Isaacs 859-323-4738

    Objective: To demonstrate reversal of the antiplatelet effects of ticagrelor with IV infusion of PB2452 and to demonstrate the clinical efficacy of PB2452 by assessment of hemostasis in ticagrelor-treated patients with uncontrolled major or life-threatening bleeding or who are undergoing urgent surgery or invasive procedure in a an open-label, single-cohort study.


    MK-5475-007: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension

    PI: David Booth, MD

    Coordinator: Heather Hesselson, PharmD 859-218-1644

    Objective: Two cohorts to evaluate the effect of MK-5475

    • versus placebo on the pulmonary vascular resistance (PVR) at Week 12
    • versus placebo on 6-minute walk distance (6MWD) at Week 12
  • Clinical research team

    John Kotter, MD
    Director, Gill Heart & Vascular Institute Cardiology Research Center

    Jennifer Isaacs, MS, MS, CCRP
    Clinical Research Administrative Director
    Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-4738
    Fax: 859-257-7383
    Email: jennifer.isaacs@uky.edu

    Stephanie Morris, CCRP
    Clinical Research Operations Manager – Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-5366
    Fax: 859-257-7383
    Email: stephanie.a.morris@uky.edu

    Research Coordinators

    Heather Hesselson, PharmD
    Phone: 859-218-1644
    Email: Heather.hesselson@uky.edu

    Ben Rushing, CCRC
    Phone: 859-323-5259
    Email: ben.rushing@uky.edu

    Travis Sexton, PhD
    Phone: 859-323-1082
    Email: Trsesxt2@uky.edu

    The division supports a clinical trial section, led by John Kotter, MD, and Clinical Research Director Jennifer Isaacs, MS, MS, CCRP. Phase 1-4 drug and device clinical trials across a multitude of areas including structural heart disease, coronary artery disease, heart failure and electrophysiology are currently in progress.

    The strength of our clinical research efforts, particularly regarding innovative catheter-based approaches to heart and vascular disease, is unmatched. We conduct leading-edge cardiovascular treatment approaches including renal denervation, left atrial pressure monitoring for heart failure, resorbable coronary stents and stem cell regenerative medicine. Historically, we have been a top enroller in multicenter trials investigating novel devices for PFO closure, left atrial pressure monitoring (to treat heart failure) and ASD closure as well as novel drugs for treatment of ACS and the prevention of secondary coronary events.

    Our strength and commitment to clinical trial research increases the accessibility of state-of-the-art treatments to patients across Kentucky that would otherwise not exist in this region of the country. The University of Kentucky’s Center for Clinical and Translational Science (CCTS) awarded by the National Institutes of Health places the university in an elite group of 60 biomedical research institutions poised to solve the toughest challenges in medicine and surgery using innovative approaches.