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
REVERSE-HF - A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients with Heart Failure and Fluid Overload
Objective: The objective of the study is 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.
PI: Andrew Kolodziej, MD
Coordinator: Travis Sexton, PhD, CCRP, 859-323-1082
CORCINCH-HF: Randomized clinical evaluation of the AccuCinch® Ventricular Restoration System in patients who present with symptomatic heart failure with reduced ejection fraction (HFrEF)
Objective: The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
PI: Andrew Leventhal, MD
Coordinator: Brianna Grimm, 859-323-7195
DAL-302 (dal-GenE-2): Phase 3, double-blind, randomized, placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular risk in a genetically defined population with a recent acute coronary syndrome
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 in subjects with a documented recent acute coronary syndrome and the AA genotype at variant rs1967309 in the ADCY9 gene.
PI: John Kotter, MD
Coordinator: Hanna Skaggs, 859-323-9887
MAGNITUDE: 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)
Objective: To evaluate the efficacy of NTLA-2001, as measured by the composite risk of cardiovascular-related mortality and cardiovascular events (urgent heart failure visits and hospitalizations due to heart failure, arrhythmia or stroke), compared to placebo.
PI: Paul Anaya, MD
Coordinator: Hanna Skaggs, 859-323-9887
PHINDER: United Therapeutics Corporation/pulmonary hypertension screening in patients with interstitial lung disease for earlier detection
Objective: The primary objective of this study is to prospectively evaluate screening strategies for pulmonary hypertension (PH) in patients with interstitial lung disease (ILD) in an effort to promote awareness and encourage screening for PH in this patient population. Results from this study will be used to identify and weigh specific clinical parameters based on their prognostic significance for right heart catheterization-confirmed PH in patients with ILD.
PI: Jimmy Smith, MD
Coordinator: Travis Sexton, PhD, CCRP, 859-323-1082
ATRIUM: 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).
PI: Amit Arbune, MD
Coordinator: Travis Sexton, PhD, CCRP, 859-323-1082
REBIRTH: Randomized evaluation of bromocriptine in myocardial recovery therapy for peripartum cardiomyopathy
Objective: To determine if bromocriptine improves myocardial recovery and clinical outcomes in women with peripartum cardiomyopathy (PPCM).
PI: Navin Rajagopalan, MD
Coordinator: Travis Sexton, CCRP, 859-323-1082
Clinical research team
John Kotter, MD
Medical 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 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
Clinical Research Coordinator
859-323-9887
hanna.power@uky.edu
Brianna Grimm, BS
Clinical Research Coordinator
859-323-7195
briigrimm@uky.edu