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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.

  • Clinical trials

    AlloMap Registry (CareDx, Inc.)

    PI: Navin Rajagopalan, MD

    • Objective: to analyze medical records and observe clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.

    For more information about this study, contact:

    Rebekah Evans, RN 
    859-323-8663 
    Email: rastan2@uky.edu

    Amulet (St. Jude Medical)

    Comparison of Amplatzer™ Amulet™ LAA occluder safety and efficacy in patients with non-valvular atrial fibrillation to Boston Scientific LAA occluder.

    PI: John Gurley, MD

    • Patients over the age of 18 with documented paroxysmal, persistent or permanent non-valvular atrial fibrillation who are also deemed suitable for LAA closure.

    For more information about this study, contact:

    Rebekah Evans, RN 
    859-323-8663 
    Email: rastan2@uky.edu

    BeAT-HF (CVRx)

    BAROSTIM NEO – Baroreflex Activation Therapy for Heart Failure

    PI: Aaron Hesselson, MD

    • Objective: To determine the safety and efficacy of the Barostim Neo system in heart failure patients. The device is designed to stimulate baroreceptors in patients with NYHA Class II or III heart failure over the age of 21.

    For more information about this study, contact:

    Laura True, BSN, RN, CCRN
    859-218-1644 
    Email: lauratrue@uky.edu

    BMS CV002004 (Bristol-Myers Squibb Research and Development)

    A Longitudinal Evaluation of Disease & Fibrosis Biomarkers in Different Groups of Heart Failure Patients to Enhance the Early Clinical Development of Compounds with Anti-Fibrotic Activity in the Heart

    PI: Vincent Sorrell, MD

    • Objective: To compare the blood levels and imaging studies in stable and acute heart failure patients

    For more information about this study, contact:

    Alex Hunter, MPH, BS, CCRP
    859-323-5259 
    Email: alexandra.hunter@uky.edu

    CALM-2 (Vascular Dynamics)

    Controlling And Lowering Blood Pressure with the MobiusHD

    PI: John Kotter, MD

    • Objective: To evaluate the safety and effectiveness of the MobiusHD system in subjects with resistant hypertension by comparing the change from baseline to 180 days in 24-hour systolic ABP between the Mobius implant and sham procedure. The MobiusHD is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via catheter.

    For more information about this study, contact:

    Alex Hunter, MPH, BS, CCRP
    859-323-5259
    Email: alexandra.hunter@uky.edu

    COMPASSION S3 (Edwards Lifesciences)

    Congenital Multicenter trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV

    PI: Andrew Leventhal, MD, PhD

    • Objective: To determine safety and efficacy of the Edwards Sapien 3 Transcatheter Heart Valve System in patients with dysfunctional right ventricular outflow tract with clinical indication for intervention.

    For more information about this study, contact:

    Jennifer Isaacs 
    859-323-4738
    Email: Jennifer.isaacs@uky.edu

    DREAM HF (Mesoblast)

    Efficacy and Safety Study of Allogeneic stem cells in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

    PI: Ahmed Abdel-Latif, MD, PhD

    • Objective: Restoring the function of damaged heart muscle with experimental study product cells.

    For more information about this study, contact:

    Viktoria Bulkley, RN, BSN
    859-323-8516
    Email: v.bulkley@uky.edu

    FIX-HF-5CA (Impulse Dynamics)

    Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System in Subjects with Moderate-to-Severe Heart Failure with Ejection Fraction between 25% and 45%

    PI: Aaron Hesselson, MD

    • Objective: Allow ongoing access to treatment of patients suffering from moderate-to-severe heart failure at selected investigational sites until the PMA order has been issued by the FDA for the OPTIMIZER System. The OPTIMIZER Smart System stimulates the heart muscle with CCM treatment.

    For more information about this study, contact:

    Laura True, BSN, RN, CCRN
    859-218-1644 
    Email: lauratrue@uky.edu

    INTELLECT 2-HF (Abbott)

    Investigation to Optimize Hemodynamic Management of HeartMateII Left Ventricular Assist Device Patients using the CardioMEMS Pulmonary Artery Pressure Sensor in Advanced Heart Failure

    PI: Maya Guglin, MD, PhD

    • Objective: To determine if management strategies applied to patients with heart failure who have a HeartMate LVAD and also a CardioMEMS HF Monitoring system will improve how they feel and what they can do. The purpose of this small study is to better understand how these two devices can be used together to help heart failure patients.

    For more information about this study, contact:

    Rebekah Evans, RN, BSN
    859-323-8663 
    Email: rebekah.evans@uky.edu

    MOMENTUM 3 CAP (St. Jude Medical)

    Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3™

    PI: Maya Guglin, MD, PhD

    • Continued Access Protocol for the HeartMate 3 LVAD
    • Subjects with advanced heart failure New York Heart Association (NYHA) Class III patients with dyspnea upon mild physical activity, or NYHA Class IV who are refractory to advanced heart failure management

    For more information about this study, contact:

    Jennifer Isaacs 
    859-323-4738 
    Email: Jennifer.isaacs@uky.edu

    OPUS Registry (Actelion)

    Opsumit Users Registry

    PI: David Booth, MD

    • Objective: This study is a prospective observational drug registry developed to further characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

    For more information about this study, contact:

    Rebekah Evans, RN 
    859-323-8663 
    Email: rastan2@uky.edu

    PFO PAS (Abbott)

    AMPLATZER PFO Occluder Post-Approval Study

    PI: John Gurley, MD

    • Objective: Clinical study intended to demonstrate the safety and effectiveness of the AMPLATZER PFO Occluder, in a post-approval setting, in patients with a PFO who have had a cryptogenic stroke.

    For more information about this study, contact:

    Alex Hunter, MPH, BS, CCRP
    859-323-5259 
    Email: alexandra.hunter@uky.edu

    QP ExCELS (Biotronik)

    Sentus QP-Extended CRT Evaluation with Quadripolar Left Ventricular Leads

    PI: Aaron Hesselson, MD

    • Objective: Clinical study intended to confirm the safety and efficacy of the Sentus QP leads to support regulatory approval, as well as to assess if pacing thresholds of the lead are in an acceptable range after implantation.

    For more information about this study, contact:

    Alex Hunter, MPH, BS, CCRP
    859-323-5259 
    Email: alexandra.hunter@uky.edu

    TAFI/ DS1040B (Daiichi Sankyo)

    A Phase 1B, Randomized, Double-Blind Placebo-Controlled, Multi-Center, Single Ascending Dose Study to Assess the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of DS-1040B When Added to Standard of Care Anticoagulation Therapy in Subjects with Acute Submassive Pulmonary Embolism

    PI: Susan Smyth, MD, PhD

    For more information about this study, contact:

    Viktoria Bulkley, RN, BSN
    859-323-8516
    Email: v.bulkley@uky.edu

    TDE-301/302 Southpaw (United Therapeutics)

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HfpEF).

    PI: David Booth, MD

    • Objective: To assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6MWD from Baseline to Week 24 in subjects with PH associated with HFpEF.

    For more information about this study, contact:

    Chris Webb, RN
    859-323-1082
    Email: Christopher.webb1@uky.edu

    TDE-401 ADAPT Registry (United Therapeutics)

    A Patient Registry of the Real-World Use of Orenitram

    PI: David Booth, MD

    • Objective: Patient registry that will follow patients who are newly initiated on Orenitram for the treatment of PAH to assess real-world use and tolerability.

    For more information about this study, contact:

    Chris Webb, RN
    859-323-1082
    Email: Christopher.webb1@uky.edu

    XIENCE Short DAPT (Abbott)

    PI: Khaled Ziada, MD

    • Objective Evaluate safety of three-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding undergoing PCI with XIENCE stent.

    For more information about this study, contact:

    Chris Webb, RN
    859-323-1082
    Email: Christopher.webb1@uky.edu

  • Clinical research team

    Khaled Ziada, MD
    Director, Gill Heart & Vascular Institute Cardiology Research Center

    Jennifer Isaacs, MS, MS, CCRP
    Cardiovascular Clinical Research Director
    859-323-4738
    jennifer.isaacs@uky.edu

    Ellen Hartman, MS
    Regulatory Coordinator
    859-323-8658
    ellen.hartman@uky.edu

    Research Coordinators

    Viktoria Bulkley, RN, BSN
    859-323-8516
    v.bulkley@uky.edu

    Rebekah Evans, RN, BSN
    859-323-8663
    rebekah.evans@uky.edu

    Alex Hunter, MPH, BS, CCRP
    859-323-5259
    alexandra.hunter@uky.edu

    Chris Webb, RN
    859-323-1082
    Email: Christopher.webb1@uky.edu

    Laura True, BSN, RN, CCRN
    859-218-1644
    lauratrue@uky.edu

    The division supports a clinical trial section, led by Khaled Ziada, 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.