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  • 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

    ALLSTAR (Capricor)
    DREAM HF (TEVA)
    Sildenafil HF (GHI)
    SURTAVI (Medtronic)
    CADENCE (Otsuka)
    ISCHEMIA (NHLBI/NYUSOM)
    CIRT (NHLBI/Brigam and Women’s)
    VEST/VEST REGISTRY (U of CA-SF)
    (VA) DIVA
    ENHANCE CRT (SJM)
    ABSORB IV (Abbott)
    TCAP (Vanderbilt and Astra Zeneca)
    Upcoming trials

    ALLSTAR (Capricor)

    Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration in patients with ischemic heart failure

    PI: Ahmed Abdel-Latif, MD, PhD

    • Treatment and/or prevention of left ventricular dysfunction following myocardial infarction

    For more information about this study, contact:

    Yvonne Taul, RN
    859-2181644
    Email: yvonne.taul@uky.edu

    Return to list »


    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

    Return to list »


    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

    Return to list »


    SURTAVI (Medtronic)

    Surgical Replacement and Transcatheter Aortic Valve Implantation. The purpose of this trial is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI.

    PIs: John Gurley, MD & Mike Sekela, MD

    For more information about this study, contact:

    Kelli Frueh, RN
    859-323-8516
    Email: kelli.frueh@uky.edu

    Return to list »


    CADENCE (Otsuka)

    Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients with Paroxysmal and Persistent Atrial Fibrillation

    PI: Samy-Claude Elayi, MD

    • Ages 18-85
    • Paroxysmal and persistent atrial fibrillation
    • Must determine eligibility prior to cardioversion

    For more information about this study, contact:

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

    Return to list »


    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

    Return to list »


    CIRT (NHLBI/Brigham and Women’s)

    Cardiovascular Inflammation Reduction Trial

    PI: Alison Bailey, 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:

    Kelli Frueh, RN
    859-323-8516
    Email: kelli.frueh@uky.edu

    Return to list »


    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

    Return to list »


    (VA) DIVA

    Drug-Eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty

    PI: Khaled Ziada, MD

    • Patients with hx of CABG who are scheduled for PCI to SVG

    For more information about this study, contact:
    Yvonne Taul, RN
    859-218-1644
    Email: yvonne.taul@uky.edu

    Return to list »


    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

    Return to list »


    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

    Return to list »


    TCAP (Vanderbilt and Astra Zeneca)

    Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia

    PI: Susan Smyth, MD, PhD

    • Patients with Severe Community Acquired Pneumonia, within 48 hours of admission

    For more information about this study, contact:

    Travis Sexton, PhD
    859-323-3617
    Email: trsex2@uky.edu

    Return to list »


    Upcoming:

    Aegis-1 (CLS) – Phase 2b, Multi-center, Randomized, Placebo-controlled, Dose-ranging Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Acute Myocardial Infarction

    PI: Alison Bailey, MD

    COMMANDER HF (Janssen) – A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

    PI: Navin Rajagopalan, MD

    RE-DUAL PCI (Boehringer Ingelheim) – A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting

    PI: Adrian Messerli, MD

    EMANATE (Pfizer) – A Phase IV Trial to Assess the Effectiveness of Apixaban Compared with Usual Care Anticoagulation in Subjects with Non-Valvular Atrial Fibrillation Undergoing Cardioversion

    PI: Adrian Messerli, MD

    Return to list »


  • 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. 

Page last updated: 4/13/2015 2:38:15 PM