Current Clinical Trials

Current Clinical Trials

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:

Partner II

Sponsor:Edwards Lifesciences, LLC
PI's:Kendra Grubb, 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-  hierarchical 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/THVcaegory.aspx
Clinical Coordinator:
Email:
Natoya Hopper

NAVIGATE-X4

Sponsor: Boston Scientific
PI:Rakesh Gopinathannair, MD
Title:Evaluation of ACUITY X4 Quadripolar Coronary Venous Leads and RELIANCE 4-FRONT Defibrillation Leads (NAVIGATE-X4)
Summary: Eligible subjects include those patients in need of a Cardiac Resynchronization Therapy Defibrillator (CRT-D) to treat heart failure. The study is a prospective observational clinical study gathering data to establish the safety, performance and effectiveness of two different leads used in a CRT-D device (the ACUITY™ X4 quadripolar coronary venous leads and the RELIANCE 4-FRONT).
For more information:
https://www.clinicaltrials.gov/ct2/show/NCT02071173?term=Boston+Scientific+NAVIGATE-X4&rank=1

Clinical Coordinator:
Email: Shari Williams

Cantos

Sponsor: Novartis Pharmaceuticals
PI
: Marcus Stoddard, MD
Title
: Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events) (CANTOS)
Summary
A randomized, placebo-controlled, trial investigating the effects subcutaneous injection of a drug named “canakinumab” (a drug to reduce inflammation) to prevent myocardial infarction in patients with stable coronary disease with elevated high-sensitivity CRP.
For more information:
https://www.clinicaltrials.gov/ct2/show/NCT01327846?term=cantos&rank=1
Clinical Coordinator:
Email Rita Longaker

Paragon HF

Sponsor: Novartis Pharmaceuticals
PI
:  Marcus Stoddard, MD
Title:
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction (PARAGON-HF)
Summary: A multi-center, randomized, parallel group active-controlled study to evaluate the efficacy and safety of LCZ696 compared to Valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) in patients with preserved ejection fraction.
For more information: https://www.clinicaltrials.gov/ct2/show/NCT01920711?term=paragon+hf&rank=1
Clinical Coordinator: Email Rita Longaker

Restage HF

Sponsor:Thoratec
PI
: Emma Birks, 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:
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, multi-center trial, evaluating the HeartMate II® LVAD 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:
Email Terry Blanton

PACE in Breast Cancer

Sponsor: James Graham Brown Cancer Center / Vanderbilt CTSA
PI: Carrie Geisberg Lenneman, MD
Title:
Predicting Adverse Cardiac Events in Breast Cancer Summary: Women treated with either an anthracycline based chemotherapy and or a Her2-antagonist for breast cancer may develop cardiotoxicity. Currently providers are unable to identify which patients will develop cardiotoxicity from chemotherapy treatment. PACE in breast cancer study is a prospective, observational study to help identify which patients are at risk for developing cardiac side-effects of breast cancer treatment.
For more information:
https://clinicaltrials.gov/ct2/show/NCT00875238?term=PACE+in+breast+cancer&rank=1
Clinical Coordinator:
Email Glenda Marker

AZ Athro PLT

Sponsor:Juan J. Badimon, Mount Sinai School of Medicine & Collaborators AstraZeneca
PI:
Andrew P. DeFilippis, MD
Title:
Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients
Summary: The purpose of this study is to compare the effects of the drug ticagrelor (BRILINTA) on blood platelet activity (clotting activity) following a recent myocardial infarction (MI) in type 2 diabetic and non-diabetic patients.  To be eligible for this study, subjects must be receiving this drug as part of their standard treatment after a recent MI.
For more information:
https://www.clinicaltrials.gov/ct2/show/NCT01823510?term=ticagrelor++and+diabetics&rank=3

Clinical Coordinator
: Email Mallory Hatfield

COBRE Grant:  Diabetes Obesity Center

Sponsor: NIH
PI: Andrew P. DeFilippis, MD
Title: Metabolomic Analysis of Atherothrombosis
Summary:The long-term goal of this project is to develop a biomarker which differentiates atherothrombotic from non-atherothrombotic MI in patients with Type-2 diabetes. Such an approach will not only improve diagnostic accuracy but could also potentially identify events at the start of coronary thrombosis, prior to myocardial necrosis, allowing for more prompt and targeted interventions.
For more information:
http://grantome.com/grant/NIH/P20-GM103492-06-5010
Clinical Coordinator: Email Mallory Hatfield

ISCHEMIA

Sponsor: NIH/NHLBI
PI: Rita Coram, MD
Title: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
Summary: The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.
For more information:https://clinicaltrials.gov/ct2/show/NCT01471522?term=ISCHEMIA&rank=8
Clinical Coordinator:
Email Shari Williams

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 de-hygrogenase 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 informationhttp://www.clinicaltrials.gov/ct2/show/NCT01774097?term=CCTRN&rank=1"
Clinical Coordinator: EmailShari Williams

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 de-identified data for patients treated with the IMPELLA 2.5, IMPELLA 5.0, IMPELLA LD or IMPELLA CPTM Cardiac Support System
Clinical Coordinator:
Email Jennifer Schuller

AlloMap

Sponsor:XDx, Inc.
PI
Andrew Lenneman, 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: EmailJennifer Schuller

Gloria

Sponsor: Boehringer Ingelheim
PI:
Marcus Stoddard, MD
Title:GLORIA-AF Registry Program (Phase II/III)
Summary: Largest prospective observational study in non-valvular atrial fibrillation (NVAF) planned at this time.  With a goal of enrolling 56,000 patients, the registry aims to unerstand the long-term use of antithrombotic treatments to reduce the risk of stroke in patients with NVAF.
For more information:https://www.clinicaltrials.gov/ct2/show/NCT01937377?term=gloria+af&rank=2
Clinical Coordinator: EmailRita Longaker

RELAX

Sponsor: Novartis
PI: Marcus Stoddard at VA / Emma Birks at ULH and KY One
Summary: RELAX - is a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin hen added to standard of care in patients admitted to hospital for Acute Heart Failure
For more information:https://clinicaltrials.gov/ct2/show/NCT02064868
Clinical Coordinator: Email Rita Longaker / ULH & KY One Email: Shari Williams

TACTICS-HF

Sponsor: Duke University
PI:
Andrew Lenneman
Title:
Targeting Acute Congestion with Tolvaptan in Congestive Heart Failure (TACTICS-HF)
Summary: The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular treatment received for shortness of breath due to heart failure will work better than the regular treatment alone. The study will also look to see if other symptoms of heart failure or problems associated with heart failure treatments, like changes in kidney function, are affected by tolvaptan. The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone.
For more information:
https://clinicaltrials.gov/ct2/show/NCT01644331
Clinical Coordinator: Email Jennifer Schuller

CIRT

Sponsor: NHLBI
PI
: Marcus Stoddard
Title:
Post MI - Cardiovascular Inflammation Reduction Trial (CIRT)
Summary: Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among patients with stable cardiovascular disease who are at increased risk indicated by persistent elevations of hsCRP.
For more information: https://clinicaltrials.gov/ct2/show/NCT01594333
Clinical Coordinator: Email Rita Longaker

 

ARTEMSIS

Sponsor: AstraZeneca
PI
: Carrie Lenneman
Title:
Affordability and Real-world Antiplatelet Treatment Effectiveness after Myocardial Infarction Study (ARTEMSIS)
Summary: The ARTEMIS trial is a practical multi center, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year.
For more information
: https://clinicaltrials.gov/ct2/show/NCT02406677
Clinical Coordinator
: Email Elleanor Fridell and Shari Williams

EMANATE

Sponsor: Pfizer
PI: Marcus Stoddard
Title: Study of the Blood Thinner, Apixaban, For patients who have an abnormal heart rhythm (Artrial Fibrillation) and expected to have treatment to put them back into a normal heart rhythm (Cardioversion)
Summary: The purpose of this study is to assess the good and bad effects ("efficacy" and "safety") of apixaban compared with warfarin in people with "AF" in whom an early cardioversion is planned.

For more information: https://clinicaltrials.gov/ct2/show/NCT02100228
Clinical Coordinator:  Email Rita Longaker