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
FACT-CRT: FACTORS ASSOCIATED WITH RESPONSE TO CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WITH NON-LBBB ECG PATTERN
PI: Karam Ayoub, MD
Coordinator: Hanna Skaggs, 859-323-9887
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.
DAL-302: A PHASE III, DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTS OF DALCETRAPIB ON CARDIOVASCULAR (CV) RISK IN A GENETICALLY DEFINED POPULATION WITH A RECENT ACUTE CORONARY SYNDROME (ACS): THE DAL-302 (DAL-GENE-2) TRIAL
PI: John Kotter, MD
Coordinator: Hanna Skaggs, 859-323-9887
Objective: The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce the risk of fatal and non-fatal myocardial infarction (MI) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.
MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double blind, Placebo controlled Study to Evaluate the Efficacy and Safety of NTLA 2001 in Participants with Transthyretin Amyloidosis with Cardiomyopathy (ATTR-CM)
PI: Paul Anaya, MD
Coordinator: Hanna Skaggs, 859-323-9887
Objective: To evaluate the efficacy of NTLA-2001, as measured by the composite risk of CV-related mortality and CV events (urgent HF visits and hospitalizations due to HF, arrhythmia, or stroke), compared to placebo.
REVERXaL: A multinational observational longitudinal study to describe the patient characteristics, health care interventions, and health outcomes of patients with major bleedings in the presence of Factor Xa inhibitor treatment.
PI: John Kotter, MD
Coordinator: Travis Sexton, CCRP, 859-323-1082
Objective: Patients administered reversal or replacement therapy (Cohort B index date) for management of major bleeding in the presence of FXa inhibitor treatment and followed up to three months after administration of reversal or replacement therapy.
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
Hanna Skaggs, BS
Research Coordinator
859-323-9887
hanna.power@uky.edu
Brianna Grimm, BS
Research Coordinator
859-323-7195
briigrimm@uky.edu