Clinical Research

Clinical Research

Clinical trials at the University of Louisville Division of Cardiovascular Medicine

Phase I Study of Cardiac Stem Cells (SCIPIO)

Our landmark SCIPIO trial of adult cardiac stem cells in patients with heart failure was the first using stem cells from the patient’s own heart. The results, published in the prestigious medical journal The Lancet, show that administration of the patient’s own stem cells regenerates dead tissue and produces a dramatic improvement in heart function and functional capacity.

Next Studies of Stem Cells

To conclusively assess the potential of adult stem cells, we are preparing to launch additional trials as a member of a prestigious network supported by the National Institutes of Health. These trials will advance our quest to revolutionize the treatment of heart failure and offer hope to millions of patients who currently have few or no options. If successful, this would be one of the biggest advances ever in cardiovascular medicine.

Currently Open for Enrollment:

RENEW

Sponsor: Baxter
PI’s: Roberto Bolli, MD and Michael Flaherty, MD, PhD
Title: A Prospective, Randomized, Double-Blind, Active-Control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of G-CSF Mobilized Autologous CD34+ Cells for the Improvement in Total Exercise Time During Standardized Exercise Testing in Subjects with Refractory Angina Pectoris and Chronic Myocardial Ischemia (CMI)
Summary: This is a bone marrow stem cell study using patients own stem cells. These stem cells will be injected in the heart in a procedure done in the Cardiac Cath Lab. We will be enrolling 7-8 patients with a diagnosis of Refractory Angina or Chronic MI. Subjects will be randomized to either the treatment/placebo arm or the standard of care arm.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01508910?term=RENEW&rank=3
www.renewstudy.com
Clinical Coordinator: Shari Williams, RN, BSN: 502-407-3259 or Email Shari Williams

Analyze ST:

Sponsor: St. Jude Medical
PI: A.Gregory Deam, MD
Title: ST Monitoring to Detect ACS Events In ICD Patients
Summary: Analyze ST is a phase IV post-market Device Study to demonstrate the safety and effectiveness of the ST monitoring Feature in the Fortify® ST ICD system (or other ICD systems with the ST Monitoring Feature). Effectiveness of the device will be evaluated by analyzing the sensitivity of the ST Monitoring Feature to detect clinical events. We will enroll approximately 72 patients who are either having a new device implant or are due for a generator change out on an existing device.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01424722?term=ST+monitoring&rank=1
https://clinical.sjmprofessional.com/clinical-studies/disease-management/AnalyzeST.aspx
Clinical Coordinator: Jennifer Schuller, BA: (502) 587-4902 or Email Jennifer Schuller

Partner II

Sponsor: Edwards Lifesciences, LLC
PI's: Matthew Williams, MD and Michael Flaherty, MD
Title: Placement of AoRTic TraNscathertER Valves Trial
Summary: The Purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT device and Delivery systems: NovaFlex (transfemoral access) and Ascendra 2 (transapical access) in patients with symptomatic, calcific, severe aortic stenosis. The primary endpoint will be a non-hierarchial composite of events including death (all-cause) and major stroke.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01314313?term=PARTNER+II&rank=1
http://www.edwards.com/products/transcathetervalve/Pages/THVcategory.aspx
Clinical Coordinator: Natoya Hopper, RN, BSN (502) 587-4177 or Email Natoya Hopper

AlloMap

Sponsor: XDx, Inc.
PI: Kelly McCants, MD
Title: Outcomes AlloMap Registry (OAR) Study
Summary: AlloMap Testing is intended to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection (ACR) at the time of testing in conjunction with standard clinical assessment. The Registry, under sponsorship by XDx, Inc., Brisbane, CA (Sponsor) will prospectively observe the clinical long-term management and outcomes of heart transplant recipients with the regular use of AlloMap testing. This Registry will address important long-term outcomes questions that cannot be answered with individual center studies.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01833195?term=Allomap+registry&rank=1
Clinical Coordinator: Jennifer Schuller, BA: (502) 587-4902 or Email Jennifer Schuller

USpella

Sponsor: Abiomed, Inc.
PI: Michael Flaherty, MD
Title: Impella 2.5, Impella 5.0, Impella LD, Impella CP Data Registry
Summary: The USpella Registry is a multi-site, retrospective observational registry for collection of deidentified data for patients treated with the IMPELLA 2.5, IMPELLA 5.0, IMPELLA LD or IMPELLA CPTM Cardiac Support System.
Clinical Coordinator: Jennifer Schuller, BA: (502) 587-4902 or Email Jennifer Schuller

ACS Biomarkers

Sponsor/Grant: American Heart Association
PI:Andrew DeFilippis, MD
Title: Early Diagnosis of Atherothrombotic Acute Coronary Syndromes
Summary: This is an investigator initiated observational Lab study attempting to identify a biomarker in blood or urine to diagnosis heart attacks sooner and more accurately. We are enrolling approximately 80 subjects locally with either Stable CAD or who present with ACS with a diagnosis of a STEMI or NSTEMI going directly to the Cath Lab for procedure.
Clinical Coordinator:

C-Pulse

Sponsor: Sunshine Heart, Inc.
PI's: Mark Slaughter, MD; Ramesh Singh, MD; Matthew Williams, MD; Emma Birks, MD; Kelly McCants, MD; Andrew Lenneman, MD
Title: C-Pulse System: A Heart Assist Device Clinical Study (COUNTER HF)
Summary: The C-Pulse Heart Assist System is an implantable, non-blood contacting, heart assist therapy for the treatment of moderate to severe heart failure. The study is a prospective, randomized, multi-center trial designed to demonstrate the safety and efficacy of the C-Pulse System in relieving heart failure symptoms in patients with ACC/AHA Stage C, NYHA Class III to ambulatory Class IV heart failure.
For more information:
http://www.sunshineheart.com
http://www.clinicaltrials.gov/ct2/show/NCT01740596?term=C-pulse&rank=1
Clinical Coordinator: Terry Blanton, RN, BSN, PCCN: (502) 594-2121 or Email Terry Blanton

RESTAGE-HF

Sponsor: Thoratec
PI's:Emma Birks, MD; Kelly McCants, MD; Mark Slaughter, MD; Ramesh Singh, MD
Title: Remission from Stage D Heart Failure
Summary: The primary objective of this study is to determine the proportion of subjects who have sufficient improvement in ventricular function (remission from HF) after undergoing a standardized LVAD plus pharmacologic recovery treatment and testing protocol to allow removal of the LVAD within 18 months. We will enroll approximately 10 subjects locally.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01774656?term=Restage+HF+Thoratec&rank=1
Clinical Coordinator: Terry Blanton, RN, BSN, PCCN: (502) 594-2121 or Email Terry Blanton

REVIVE IT

Sponsor: Francis Pagani, MD, PhD/University of Michigan in collaboration with NHLBI and Thoratec Corporation.
PI's: Mark Slaughter, MD and Emma Birks, MD
Title: Randomized Evaluation of VAD InterVEntion Before Inotropic Therapy- REVIVE-IT
Summary: REVIVE-IT is a two-part study consisting of a trial and a registry. The REVIVE-IT Trial is a prospective, randomized, open-label, multicenter trial, evaluating the HeartMate II® LVAS versus a control group consisting of optimal medical management (OMM) in selected non-inotrope dependent, ambulatory, moderately advanced heart failure patients who are not candidates for heart transplantation based upon assessment of comorbidities and age. Approximately 5-6 subjects will be enrolled locally.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01369407?term=REVIVE+IT&rank=1
Clinical Coordinator: Terry Blanton, RN, BSN, PCCN: (502) 594-2121 or Email Terry Blanton

CCTRN NETWORK:

Description of Network: The CCTRN is a network of physicians, scientists, and support staff dedicated to studying stem cell therapy for treating heart disease. The goals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with cardiovascular disease, and to share knowledge quickly with the healthcare community. The network is funded by the NHLBI/NIH and consists of seven elite stem cell centers nationwide including the University of Louisville. As a part of the network we will be a participating site in several upcoming stem cell studies. The first of these studies is listed below.
Network Website: https://ccct.sph.uth.tmc.edu/CCTRN/default.aspx

PACE (CCTRN Network Study)

Sponsor: NHLBI/NIH (CCTRN)
PI: Roberto Bolli, MD
Title: Clinical and MR Imaging Assessments in Patients with Intermittent Claudication Following Injection of Bone Marrow Derived ALDH Bright Cells
Summary: This is a randomized, Phase II, double blind, placebo controlled clinical trial that will assess the effect of autologous bone marrow derived aldehyde dehygrogenase bright cells delivered by direct intramuscular injections to patients with athersclerotic peripheral arterial disease and intermittent claudication. Patient safety of this cell-based therapy will be evaluated. The primary endpoint of the study is the change in peak walking time at 6 months compared to baseline. Approximately 8 subjects will be enrolled locally.
For more information:
http://www.clinicaltrials.gov/ct2/show/NCT01774097?term=CCTRN&rank=1"
Clinical Coordinator: Shari Williams, RN, BSN: (502) 407-3259 or Email Shari Williams