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

OPTIMIZER SMART POST-APPROVAL STUDY

PI: Aaron Hesselson, MD
Coordinator: Ronald Smith, 859-323-7195

Objective: To evaluate 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.

FACT-CRT:  FACTORS ASSOCIATED WITH RESPONSE TO CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WITH NON-LBBB ECG PATTERN 

PI: Aaron Hesselson, MD
Coordinator: Ronald Smith, 859-323-7195

Objective: We aim to prospectively validate previously identified predictors of echo response to CRT-D in HF patients with non-LBBB, and identify novel ECG variables and echocardiography variables to predict response.

AIM HIGHer: ASSESSMENT OF IMPLANTABLE CCM IN THE HEART FAILURE GROUP WITH HIGHER EJECTION FRACTION 

PI: Gaurang Vaidya, MD
Coordinator: Ronald Smith, 859-323-7195

Objective: Demonstrate that CCM therapy improves functional capacity and health status in subjects with symptomatic heart failure with LVEF > 40 and < 60%.

REVERSE-HF: Ultrafiltration versus IV Diuretics in Worsening Heart Failure

PI: Andrew Kolodziej, MD
Coordinator: Travis Sexton, PhD, CCRP, 859-323-1082

Objective: To evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable loop diuretics in patients with an acute exacerbation of chronic heart failure (HF) and congestive physiology who are unresponsive to medical management.

VICTORION-2 PREVENT:  CKJX839B12302

PI: John Kotter, MD
Coordinator: Travis Sexton, CCRP, 859-323-1082

Objective: To demonstrate the superiority of inclisiran in reducing the risk of 3P-MACE in participants with clinically evident CV disease and elevated LDL-C levels, when administered in addition to well-tolerated high-intensity statin therapy.

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, CCRP, 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 in 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: Travis Sexton, CCRP, 859-323-1082

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

ATRIUM - A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Compared To Placebo in Hospitalized Participants with Immune Checkpoint Inhibitor Associated Myocarditis 

PI: Amit Arbune, MD
Coordinator:  Travis Sexton, CCRP, 859-323-1082

Objective: The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI).

REBIRTH: Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy for Peripartum Cardiomyopathy

PI: Navin Rajagopalan, MD
Coordinator: Travis Sexton, CCRP, 859-323-1082
Objective: To Determine if bromocriptine improves myocardial recovery and clinical outcomes in women with PPCM.

Clinical research team

John Kotter, MD
Director, Gill Heart & Vascular Institute Clinical Research

Jennifer Isaacs, MS, MS, CCRP
Clinical Research Services Director
Interventional Services
Gill Heart & Vascular Institute Clinical Research
859-323-4738 
jennifer.isaacs@uky.edu

Stephanie Morris, BS, CCRP
Clinical Research Operations Manager 
Interventional Services
Gill Heart & Vascular Institute Clinical Research
859-323-5366
stephanie.a.morris@uky.edu

Research Coordinators

Travis Sexton, PhD, CCRP
Clinical Research Coordinator
859-323-1082
trsext2@uky.edu

Ronald Smith, MA
Research Coordinator
859-323-7195
ronald.t.smith@uky.edu