Clinical Trials at Gill

CONFIRMATION-HF: COmbiNed eFfIcacy and safety of an eaRly, intensive MAnagement sTrategy with fInerenOne and SGLT2 iNhibitor in patients hospitalized with Heart Failure

Objective: The primary study objective is to determine whether a strategy including usual care plus early initiation of intensive combination therapy with finerenone and empagliflozin provides superior clinical outcomes compared with local usual care in patients with HHF.

PI:  Maya Ignaswzewski, MD
Coordinator: Travis Sexton, PhD, 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

FINALITY-HF: A randomized, double-blind, placebo-controlled pragmatic study to evaluate FINerenone on clinicAL effIcacy and safeTY in patients with Heart Failure and reduced ejection fraction who are intolerant of or not eligible for treatment with steroidal mineralocorticoid receptor antagonists.

Objective: The primary objective is to evaluate the efficacy and safety of finerenone in participants with HFrEF who are intolerant of or not eligible for treatment with sMRA. The safety objective is to assess safety and tolerability of finerenone.

PI: Sonu Abraham, MD
Coordinator: Travis Sexton, PhD, 859-323-1082

INNOVATE: Investigation of a Novel, magNetically levitated VAD for the treatment of refractOry left Ventricular heArT failurE

Objective: The objective of the study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HM3 LVAS when used for the treatment of patients with advanced, refractory, left ventricular heart failure.

PI: Emma Birks, MD
Coordinator: Brianna Grimm, 859-323-7195

REDEFINE-HF: RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure

Objective: To determine whether finerenone reduces total (first and subsequent) HF events and CV death compared with placebo in patients hospitalized with acute decompensated HFmrEF/HFpEF.

PI: Paul Anaya, MD, PhD
Coordinator: Travis Sexton, PhD, 859-323-1082

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

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:  Maya Ignaswzewski, 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

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