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