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  • Gill Clinical Research Unit

    The Gill Heart Institute Cardiology Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase I-IV multicenter trials, support of the infrastructure for clinical trials as well as education of faculty and fellows in clinical research methodology.

    Since its inception, the Gill Heart Institute Cardiology Research Center has been a top enroller in multicenter trials including novel devices for patent foramen ovale (PFO) closure, left atrial pressure monitoring to treat heart failure and percutaneous closure of atrial septal defect (ASD).  



  • Amplatzer Cardiac Plug 

    The purpose of this study is to evaluate the safety and efficacy of the Amplatzer® Cardiac Plug in comparison to anticoagulants warfarin (Coumadin®) and dabigatran (Pradaxa®) in patients with non-valvular atrial fibrillation.

    Principal investigator: John C. Gurley, MD 

    For more information about this study, contact:

    Mandy Hatfield, BA, CCRP
    859-323-1082
    Email: mlhatf0@uky.edu  

  • ASD 

    Closure of Atrial Septal Defects with the AMPLATZER Septal Occluder – Post Approval Study

    The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder.

    Principal investigator: John C. Gurley, MD 

    For more information about this study, contact:

    Tiffany Sandlin, RN
    859-323-4738
    Email: tasand2@uky.edu 

  • CADENCE 215

    Ascending Dose Study of OPC-108459 Intravenous Infusions in patients with paroxysmal and persistent atrial fibrillation (CADENCE 215)

    A clinical trial to test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects. This trial will test the pharmacokinetic and pharmacodynamic characteristics of ascending doses of OPC-108459 in separate populations of paroxysmal and persistent AF subjects. The trial will consist of two parts. Each part will evaluate two populations of subjects presenting for cardioversion in a hospital setting. Cohorts of paroxysmal and persistent subjects may have their dose increased independently. Each cohort will be evaluated separately for all analysis parameters.

    Principal investigator: Samy C. Elayi, MD  

    For more information about this study, contact:

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

  • COMPASS 2

    Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) (Compass 2)

    This study will investigate the effects of the combination of bosentan and sildenafil. Patients with symptomatic PAH treated with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks will be randomized to placebo or bosentan 125 mg b.i.d. All randomized patients will be treated with study drug until the predefined target number of morbidity/mortality events is reached.

    Principal investigator: David C. Booth, MD 

    For more information about this study, contact:

    Tiffany Sandlin, RN
    859-323-4738
    Email: tasand2@uky.edu 

  • Clinical trials

    CSL—112

    A Phase 2a, Multi-center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of a Single Intravenous Infusion of CSL112 in Patients With Stable Atherothrombotic Disease

    Reconstituted high-density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.

    Principal investigator: Alison L. Bailey, MD  

    For more information about this study, contact:

    Kay Moles, RN; or Rebekah Evans, RN
    859-323-8516 or 859-323-8663
    Email: kmoles2@uky.edu or rastan2@uky.edu  

  • IMPROVE-IT

    A Multicenter, Double-Blind, Randomized Study to Establish Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs. Simvastatin Monotherapy in High-Risk Subjects Presenting with Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE-IT)

    This is a randomized, active-control, double-blind study of subjects with stabilized high-risk acute coronary syndrome (ACS). The primary objective is to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination 10/40 (single tablet, under the brand VYTORIN in the United States) compared with Simvastatin 40 mg. As per the original protocol, if low-density lipoprotein cholesterol (LDL-C) response was inadequate, the dose of simvastatin in the VYTORIN arm or simvastatin arm, could be increased to 80 mg (Note: per June 2011 protocol amendment, criteria for continued use of 80 mg simvastatin were modified and new increases of simvastatin dose to 80 mg were stopped). Clinical benefit will be defined as the reduction in the risk of the occurrence of the composite endpoint of CV death, major coronary events, and stroke.

    Principal investigator: John Gurley, MD 

    For more information about this study, contact:

    Kay Moles, RN
    859-323-8516
    Email: kmoles2@uky.edu 

  • IPAC

    Investigation in Pregnancy Associated Cardiomyopathy (IPAC)

    Peripartum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other unknown causes, can lead to a process of inflammation of the heart muscle which can weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy is not well understood and if it differs from those women who develop cardiomyopathy from a virus is unknown. This study has been proposed to look at genetic information (DNA) as well as the immune system (the body's response to fight off infections and/or viruses) to find possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.

    Principal investigator: Navin Rajagopalan, MD 

    For more information about this study, contact:

    Tiffany Sandlin, RN
    859-323-4738
    Email: tasand2@uky.edu 

  • ISCHEMIA

    International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA)

    The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those with an acute coronary syndrome, ischemic heart failure, resuscitated cardiac arrest or refractory symptoms.

    Principal investigator: David Booth, MD 

    For more information about this study, contact:

    Ellen Lacey
    859-323-8381
    Ellen.Lacey@uky.edu 

  • LAPTOP-HF

    Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy (LAPTOP-HF)

    The purpose of this clinical study is to evaluate the safety and clinical effectiveness of use of a physician-directed, patient self-management system, guided by left atrial pressure measurements, for use in patients with heart failure. The system allows patients to adjust their HF medications daily based on a physician-directed prescription plan and their current HF status, similar to the manner in which diabetes patients manage their insulin therapy. The goal of the LAPTOP-HF study is to demonstrate reductions in episodes of worsening heart failure (HF) and hospitalizations in patients who are managed with the left atrial pressure (LAP) management system (treatment group) versus those who receive only the current standard of care (control group

    Principal investigator: John Gurley, MD 

    For more information about this study, contact:

    Rebekah Evans, RN
    859-323-8663
    rastan2@uky.edu IRB may be reached by phone at 859-257-9428 or toll free at 1-866-400-9428. 

  • PREMIUM

    PREMIUM Migraine Trial: A prospective randomized investigation to evaluate incidence of headache reduction in subjects with migraine and PFO using the Amplatzer® PFO Occluder compared to medical management

    The Purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (a hole in the heart), using the Amplatzer® PFO Occluder, on the incidence of migraine headaches.

    Principal investigators: 

    John C. Gurley, MD
    Joseph Berger, MD (Neurologist)

    For more information about this study, contact:

    Mandy Hatfield, CCRP
    859-323-1082
    Email: mlhatf0@uky.edu 

  • PROMISE

    PROspective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE)

    A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.

    Principal investigator: Vincent L. Sorrell, MD 

    For more information about this study, contact:

    Ellen Lacey
    859-323-8381
    Email: Ellen.Lacey@uky.edu 

  • SEATTLE II

    A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE). (SEATTLE II)

    The Purpose of this study is to evaluate the EKOS catheter in conjunction with Alteplase designed to treat patients with massive and sub-massive pulmonary embolism. The study will determine the improvement in heart function after treatment with the Ekosonic Endovascular System.

    Principal Investigator: John C. Gurley, MD 

    For more information about this study, contact:

    Mandy Hatfield, BA, CCRP
    (859) 323-1082
    Email: mlhatf0@uky.edu 

  • SOLID TIMI-52

    The Stabilization Of pLaques using Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)

    A Clinical Trial to test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

    Principal investigator:  Charles L. Campbell, MD  

    For more information about this study, contact:

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

  • SYMPLICITY HTN-3

    A Clinical Trial to Evaluate renal denervation in patients with uncontrolled hypertension (Symplicity HTN-3)

    The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal surface of the renal artery. Previous trials showed ≥ 10 mmHg drop of systolic blood pressure in 84% of the patients.

    Principal investigator: Khaled Ziada, MD
    Email: kziad2@uky.edu 

    For more information about this study, contact:

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

  • VEST

    VEST Study-The Vest Prevention of Early Sudden Death Trial

    The Purpose of this study is to find whether wearing a defibrillator can prevent death from an abnormal heart rhythm in the 3 months after a heart attack.

    Principal investigator: Samy-Claude Elayi, MD 

    For more information about this study, contact:

    Mandy Hatfield, CCRP
    859-323-1082
    Email: mlhatf0@uky.edu 

  • 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: 12/27/2013 2:02:43 PM