• Gill Clinical Research Unit

    The Gill Heart Institute Cardiology Clinical Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase I-IV multicenter drug and device trials, investigator-initiated protocols as well as 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 Heart staff in clinical research methodology is at the core of our continued success.

    Since its inception, the Gill Heart 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

    CURRENT ENROLLING CLINICAL TRIALS

    COMPASSION S3 (Edwards Lifesciences)
    CardioMEMS HF System PAS (Post Approval Study) (St. Jude Medical)
    FAME 3 (Stanford University)
    TWILIGHT (Mt. Sinai Medical School)
    VOYAGER PAD (Bayer Pharmaceuticals)
    MOMENTUM 3 CAP (St. Jude Medical)
    AEGIS 2001 (CSL Berhing)
    DREAM HF (TEVA)
    Sildenafil HF (GHI)
    ISCHEMIA (NHLBI/NYUSOM)
    CIRT (NHLBI/Brigam and Women’s)
    VEST/VEST REGISTRY (U of CA-SF)
    ENHANCE CRT (SJM)
    ABSORB IV (Abbott)
    Spyral HTN ON Meds (Medtronic)
    Spyral HTN OFF Meds (Medtronic)

    COMPASSION S3 (Edwards Lifesciences)

    Congenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3 interventIONal THV

    PI: Andrew Leventhal, MD, PhD

    • 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

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    CardioMEMS HF System PAS (Post Approval Study) (St. Jude Medical)

    PI: Maya Guglin, MD, PhD

    • Continued collection of safety and efficacy data following FDA approval of device

    For more information about this study, contact:

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

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    FAME 3 (Stanford University)

    Fractional flow reserve versus angiography for multivessel evaluation (FAME) 3 Trail

    PI: Khaled Ziada, MD (UK) and Ahmed Abdel-Latif, MD, PhD (VA)

    • A comparison of fractional flow reserve-guided percutaneous coronary intervention and coronary artery bypass graft surgery in patients with multivessel coronary artery disease

    For more information about this study, contact:

    Caroline Rodgers
    859-323-1082
    Email: Caroline.rodgers@uky.edu

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    TWILIGHT (Mt. Sinai Medical School)

    Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

    PI: David Moliterno, MD

    • To determine the impact of ticagrelor alone vs. ticagrelor plus aspirin in reducing clinically relevant bleeding and ischemic adverse events among high-risk patients who had PCI with at least one drug-eluding stent

    For more information about this study, contact:

    Alexandra Telfair-Hull
    859-218-2880
    Email: Alexandra.hull@uky.edu

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    VOYAGER PAD (Bayer Pharmaceuticals)

    PI: Khaled Ziada, MD

    • Evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of major thrombotic vascular events (MI, ischemic stroke, cardiovascular death, major amputation of a vascular etiology) in symptomatic PAD patients undergoing lower extremity revascularization

    For more information about this study, contact:

    Alexandra Telfair-Hull
    859-218-2880
    Email: Alexandra.hull@uky.edu

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    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

    For more information about this study, contact:

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

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    AEGIS 2001 (CSL Berhing)

    A phase 2 study looking at safety of CSL112 in patients following an MI. CSL112 is a novel formulation of apoA-I purified from human plasma and reconstituted to form HDL particles.

    PI: John Kotter, MD

    • Qualified patients who provide consent will receive four 2-hour infusions, 7 days apart, during the active treatment phase

    For more information about this study, contact:

    Caroline Rodgers, RN
    859-323-1082
    Email: Caroline.rodgers@uky.edu

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    DREAM HF (TEVA)

    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

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

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu

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    Sildenafil HF (GHI)

    Sildenafil in Heart Failure with Reactive Pulmonary Hypertension

    PI: Maya Guglin, MD, PhD

    • To determine whether sildenafil can improve exercise tolerance measured by 6 minute walk distance
    • To determine whether sildenafil can improve hemodynamics, right ventricular function, or quality of life

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu

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    ISCHEMIA (NHLBI/NYUSOM)

    International Study of Comparative Health Effectiveness with Medical and Invasive Approaches invasive strategy ( initial management with cath) vs. conservative strategy (initial management with optimal medical therapy [OMT] and provisional cath if OMT fails) in ischemic patients

    PI: David Booth, MD

    • Patients with at least moderate ischemia on a stress imaging test

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: Yvonne.taul@uky.edu

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    CIRT (NHLBI/Brigham and Women’s)

    Cardiovascular Inflammation Reduction Trial

    PI: Adrian Messerli, MD

    • Investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack

    For more information about this study, contact:

    Heather Shinall, RN
    859-323-8516
    Email: h.shinall@uky.edu 

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    VEST/VEST Registry (U of CA-SF)

    Non-invasive wearable automatic defibrillator vest will reduce mortality in first 90 days post MI in pts w/ LV dysfunction (≤35%)

    PI: Samy-Claude Elayi, MD

    • STEMI / NSTEMI with EF ≤ 35%
    • LifeVest vs. medical management for 3 months
    • Registry is continuation of data collection for up to 8 years annually

    For more information about this study, contact:

    Yvonne Taul, RN
    859-218-1644
    Email: yvonne.taul@uky.edu

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    Enhance CRT (SJM)

    CRT Implant Strategy using the longest electrical delay for non-LBB patients; randomized, post-market pilot study

    PI: Gustavo Morales, MD

    • Patients with non-left bundle branch block, eligible for bi-ventricular ICD implant

    For more information about this study, contact:

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

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    ABSORB IV (Abbott)

    A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de Novo Native Coronary Artery Lesions.

    PI: Khaled Ziada, MD

    • Patients with indication for elective LHC and possible PCI

    For more information about this study, contact:

    Caroline Rodgers, RN
    859-323-1082
    Email: caroline.rodgers@uky.edu

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    Spyral HTN ON Meds (Medtronic)

    Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in patients with Uncontrolled Hypertension on Standard Medical Therapy

    PI: Khaled Ziada, MD

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu 

    Return to list »


    Spyral HTN OFF Meds (Medtronic)

    Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in patients with Uncontrolled Hypertension in the absence of antihypertensive medications

    PI: Khaled Ziada, MD

    For more information about this study, contact:

    Heather Shinall
    859-323-5259
    Email: h.shinall@uky.edu 

    Return to list »

  • Clinical research team

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

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

    Mary Roycraft
    Regulatory Coordinator
    859-323-8658
    mary.roycraft@uky.edu

    Research Coordinators

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

    Caroline Rodgers, RN, CCRC
    859-323-1082
    caroline.rodgers@uky.edu

    Heather Shinall, MA, CCRP
    859-323-5259
    h.shinall@uky.edu

    Yvonne Taul, RN, CCRC
    859-218-1644
    yvonne.taul@uky.edu

    Alexandra Telfair-Hull 
    859-218-2880 
    alexandra.hull@uky.edu


    The division supports a clinical trial section, led by Khaled Ziada, MD, and clinical research manager Jennifer Isaacs, MS, MS, CCRP. Phase 1 - IV 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 Clinical and Translational Science (CTSA) Program 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.

  • Please Note:

    Study coordinators and research nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a UK doctor or clinic location to meet your health care needs. 

    Although the studies described on this website may have potential benefits as described, the University of Kentucky and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study. 

    The information posted on this site is consistent with the research reviewed and approved by the University of Kentucky Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The UK IRB may be reached by phone at 859-257-9428 or toll free at 1-866-400-9428.