Multiple cArdiac seNsors for mAnaGEment of Heart Failure Save

Date Added
May 8th, 2018
PRO Number
Pro00075530
Researcher
Michael Gold

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Keywords
Cardiovascular
Summary

Cardiac implantable electronic devices (Implantable Cardioverter Defibrillators (ICD),cardiac resynchronization therapy (CRT)) with sensors have been used to develop Heart Failure diagnostics which indicate early changes leading up to hospitalizations. The study is testing a feature that can help predict when your heart failure is getting worse. The feature is called HeartLogic™ Heart Failure Diagnostic Service, or simply HeartLogic.

Institution
MUSC
Recruitment Contact
Deborah Everidge
8437922944
adamsde@musc.edu

VITROS® Immunodiagnostic Products hs Troponin I US Sample Collection Protocol Save

Date Added
May 8th, 2018
PRO Number
Pro00076320
Researcher
Gary Headden

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Keywords
Cardiovascular, Heart, Non-interventional
Summary

Roughly 8-10 million patients complaining of chest pain come to an Emergency Department (ED) annually in the United States. Quickly determining if you are having a heart attack is critical for improving your chances of survival. Cardiac troponin is a protein that is used as a biomarker (biological marker) to indicate damage to the heart muscle. Cardiac troponin lab tests that are currently used in the United States do not have the ability to detect low levels of troponin. There are more sensitive troponin tests that are primarily used outside the US, that are able to detect lower levels of cardiac troponin within 90-180 minutes instead of 5 or 6 hours. This allows for the early identification of individuals at a higher risk for heart damage and these patients benefit from early diagnosis and treatment. Delaying the treatment of a heart attack increases the chance of dying or being permanently disabled. This study will collect blood samples from people coming to the Emergency Department complaining of chest pain in order to measure this troponin lab test's ability to accurately detect troponin levels.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@musc.edu

A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene Mutation Save

Date Added
April 10th, 2018
PRO Number
Pro00075889
Researcher
Daniel Judge

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Keywords
Cardiovascular, Drug Studies, Genetics
Summary

The purpose of this research study is to test if ARRY-371797 is safe and effective in treating dilated cardiomyopathy caused by a genetic mutation to the LMNA gene. This will be demonstrated by the functional capacity of patients in their 6-minute walk tests and quality of life questionnaires.

Institution
MUSC
Recruitment Contact
Anita Smalls
843-876-5011
smaani@musc.edu

A Phase 2, Randomized, Placebo-controlled, Dose-ranging Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Patients with Symptomatic Transthyretin Amyloid Cardiomyopathy Save

Date Added
April 10th, 2018
PRO Number
Pro00076210
Researcher
Daniel Judge

Silhouette
Keywords
Cardiovascular
Summary

Amyloidosis (ATTR) Cardiomyopathy (CM) is a progressive, fatal disease in which amyloid deposits build up slowly, over the course of many years to cause organ damage. This study is evaluating the safety and tolerability of a new drug called AG10 administered to adult patients with symptomatic transthyretin amyloid cardiomyopathy. The participant will be randomized to the study drug or placebo and take the study drug two times per day for 28 days.

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
8437925863
tecklenb@musc.edu

The Association between Arterial Stiffness and Cognitive Impairment Risk in non-stroke controls (TAASCIR) Save

Date Added
February 26th, 2018
PRO Number
Pro00074521
Researcher
Joy Jones buie

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Keywords
Brain, Cardiovascular, Hypertension/ High Blood Pressure, Minorities, Stroke, Stroke Recovery
Summary

The purpose of this research study is to understand the association between heart and brain health in a population of 40-75 year olds. In this study, we will work to better understand blood vessel stiffness and brain function in African American and non-Hispanic white individuals. You will be asked to give blood during the study visit. Additional information will be obtained to help the researcher better understand the blood vessel and brain function data collected. There is only one study visit that last roughly 2 hours and compensation will be available.

Institution
MUSC
Recruitment Contact
Joy Jones Buie
8437926098
jonejn@musc.edu

Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation Save

Date Added
February 13th, 2018
PRO Number
Pro00072452
Researcher
Jeffrey Winterfield

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Keywords
Cardiovascular, Heart
Summary

The purpose of this research study is to collect information on the safety of the TactiCath SE ablation catheter when it is used to treat atrial fibrillation.This study will collect information about the success of the procedure and report on the number and type of follow-up problems that may occur during or after the ablation procedure (sometimes called adverse events). Data collected for this study will be submitted for review and approval by the FDA.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis ? Above and Below the Knee Save

Date Added
February 13th, 2018
PRO Number
Pro00073943
Researcher
Thomas Todoran

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Keywords
Cardiovascular
Summary

Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

Diabetes, modified lipoproteins, and preeclampsia Save

Date Added
January 10th, 2018
PRO Number
Pro00070368
Researcher
Timothy Lyons

Silhouette
Keywords
Cardiovascular, Diabetes, Hypertension/ High Blood Pressure, Pregnancy
Summary

Pre-eclampsia (PE) happens in pregnancy. It features new onset high blood pressure. It is a major cause of problems to the mother and unborn child. It can lead to health problems in mother and child in the future, which causes a public health problem. We do not know everything about it, but we think it starts in the placenta (the organ that nourishes the unborn child). At this time, we do not know who will get PE. We want to study the placenta, to learn more about the disease.

Institution
MUSC
Recruitment Contact
Misti Leyva
8437921933
leyva@musc.edu

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF). Save

Date Added
January 3rd, 2018
PRO Number
Pro00065220
Researcher
Ryan Macnevin
Keywords
Cardiovascular, Coronary Artery Disease, Heart
Summary

The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms.

Inclusion criteria:
?Male or female patient, age >= 18 years at screening.
?Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
?Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1
?Stable dose of oral diuretics, if prescribed
?Signed and dated written ICF (informed consent form)
?Further inclusion criteria apply

Exclusion criteria:
?Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1
?Heart transplant recipient or listed for heart transplant
?Acute decompensated HF (Heart Failure)
?Systolic blood pressure (SBP) >= 180 mmHg at Visit 2.
?Symptomatic hypotension and/or a SBP < 100 mmHg
?Indication of liver disease,
?Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis
?History of ketoacidosis
?Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor
?Currently enrolled in another investigational device or drug trial
?Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors
?Women who are pregnant, nursing, or who plan to become pregnant while in the trial
?Further exclusion criteria may apply

Institution
Palmetto
Recruitment Contact
Ryan MacNevin
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

Safety and Efficacy of Periprocedural Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation Save

Date Added
December 12th, 2017
PRO Number
Pro00070088
Researcher
Jeffrey Winterfield

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to learn if taking a drug called apixaban, given orally, before and after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in VT (ventricular tachycardia) patients. Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is compared to Aspirin. Aspirin is mainly used to treat fever, pain and inflammatory conditions such as arthritis.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

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