A Phase 2b, Double-Blind, Placebo-Controlled, Multinational , Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR (AAV1/SERCA2a) in Subjects with Heart Failure + save

Date Added
May 14th, 2013
PRO Number
Pro00016711
Researcher
Adrian Van bakel
Keywords
Cardiovascular
Summary

Subjects in this study will be over the age of 18 years and male or female (non-pregnant). Subjects must have advanced, chronic heart failure. Subjects will receive one dose of the Mydicar or placebo into the arteries of the heart and then be followed for up to 3 years to see the safety and effect on heart failure-related hospitalizations.

Institution
MUSC
Recruitment Contact
Mariann Schulz
843-876-5009
schulzmt@musc.edu

Dapagliflozin Evaluation of Cardiovascular Events (DECLARE – TIMI 58); A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3b Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes + save

Date Added
May 14th, 2013
PRO Number
Pro00023956
Researcher
James Thomas
Keywords
Cardiovascular, Cholesterol, Diabetes, Hypertension/ High Blood Pressure
Summary

Research study looking for participants with type 2 diabetes and either cardiovascular disease or risk factors for cardiovascular disease (e.g. abnormal cholesterol, high blood pressure or tobacco use.) This study is being carried out to see if a new investigational drug called dapagliflozin when added to current treatment for diabetes is effective in reducing cardiovascular events such as heart attack, stroke, and death from heart disease, when compared with placebo (inactive pill having no effect). Medications, all study visits, blood work and study procedures are free of charge.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-876-5012
macnichd@musc.edu

S1P Deficiency Prolongs Endothelial Barrier Recovery After Fontan Operation + save

Date Added
May 7th, 2013
PRO Number
Pro00017515
Researcher
Sinai Zyblewski
Keywords
Cardiovascular, Heart, Pediatrics
Summary

Capillary leakage leading to persistent pleural effusions and multiorgan dysfunction continue to be a significant post-operative problem in children following cardiopulmonary bypass (CPB). Studies to be performed as part of this research program will test the hypothesis that children with persistent pleural effusions have insufficiencies in an HDL-associated lipid, sphingosine-1-phosphate (S1P), that controls blood vessel barrier maintenance. If plasma levels of S1P are found to be predictive of persistent pleural effusions and prolonged post-operative recovery time after CPB then exogenous administration of S1P may hold promise in improving post-operative recovery after CPB.

Institution
MUSC
Recruitment Contact
Patricia Infinger
(843) 792-7857
infingep@musc.edu

PEDIATRIC HEART NETWORK LONGITUDINAL FONTAN STUDY (FONTAN 3) + save

Date Added
May 7th, 2013
PRO Number
Pro00017096
Researcher
Andrew Atz
Keywords
Cardiovascular, Exercise, Genetics, Heart, Pediatrics, Surgery
Summary

A follow-up study (Fontan 2) at an average of 6 years after Fontan 1 has recently been completed. A limited re-evaluation of the original Fontan 1 cohort utilized the following outcomes: vital status, functional health status, interim medical events, access to health care and self-reported availability and willingness to participate in future studies. We are continuing to follow this unique group of individuals in order to assess how they are coping with this chronic disease process.

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care + save

Date Added
May 7th, 2013
PRO Number
Pro00016550
Researcher
Andrew Atz
Keywords
Cardiovascular, Genetics, Heart, Pediatrics
Summary

The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-1213
choudhur@musc.edu

Vitamin D to improve endothelial function in lupus patients + save

Date Added
April 16th, 2013
PRO Number
Pro00009197
Researcher
James Oates
Keywords
Cardiovascular, Lupus, Vascular, Vitamin D
Summary

This study is looking at Vitamin D and cardiovascular function in lupus patients who have low vitamin D levels. In this study, we expect to screen 50 or more participants for vitamin D deficiency by drawing blood by vein (up to 10 ml or two teaspoons). Of the first 32 screened who are vitamin D deficient, we will randomize (assign by chance) 16 patients to receive either a low, non replenishing dose (400 units (IU) daily) and 16 patients to receive a high, replenishing dose of vitamin D (5,000 IU daily) after measuring their blood vessel endothelial function by flow mediated dilation (FMD) and performing a history, physical examination, blood draw (up to 60 ml or 4 tablespoons), and urine collection. FMD is measured by putting an ultrasound probe (like a microphone with some jelly on top) on a blood vessel in the arm. Measures are taken before and after a blood pressure cuff is inflated on the arm to cut off blood supply for five minutes and then several minutes after release. After patients have taken vitamin D for 16 weeks, we will measure FMD again to determine if the endothelial function improves on the higher dose of vitamin D. We will perform a history and physical and draw blood (up to 60 ml or 4 tablespoons) and collect urine to determine mechanisms through which vitamin D might be improving vascular function.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-0549
powab@musc.edu

IDENTIFY-HF: Integrated Diagnostic Evaluation in Non-Therapy Devices For the Study of Heart Failure + save

Date Added
April 8th, 2013
PRO Number
Pro00016665
Researcher
Michael Zile
Keywords
Cardiovascular
Summary

The study involves subjects who have the Reveal implantable cardiac monitor. This monitor records information about the heart. Subject in this study will either have their heart information reviewed by the doctor and study staff to manage their heart failure or have their heart failure managed by standard ways (monitoring signs and symptoms of heart failure). The study will see if one way of managing heart failure versus the other has different outcomes for subjects.

Institution
MUSC
Recruitment Contact
Mariann Schulz
(843) 876-5009
schulzmt@musc.edu

Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass + save

Date Added
April 2nd, 2013
PRO Number
Pro00016545
Researcher
Eric Graham
Keywords
Cardiovascular, Drug Studies, Heart, Pediatrics
Summary

This is a single-center, prospective, randomized, double blind, placebo controlled study of intraoperative MP in neonates undergoing CPB. Patients will be allocated to one of the 2 study groups in the ratio of 1:1. The randomization will be stratified by corrective vs. palliative surgery. The Primary Endpoint is a composite morbidity-mortality outcome, evaluated as intention to treat (ITT). Secondary endpoints include inotropic score, incidence of LCOS, fluid balance, ICU stay parameters, levels of inflammatory markers, safety parameters, and neurodevelopmental outcomes at 1 year. A two-sided test with a type I error rate of 0.05 will be used for all endpoints with no adjustments of the p-value for multiple testing.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-1213
choudhur@musc.edu

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches + save

Date Added
March 19th, 2013
PRO Number
Pro00018413
Researcher
William Wince
Keywords
Cardiovascular
Summary

This is a study comparing 2 different strategies for managing heart disease. One strategy called the invasive strategy will use early heart catheterization along with optimal medications to treat stable heart disease. The other strategy called conservative strategy will use optimal medications alone and use cardiac catheterization for patients once heart disease symptoms worsen.

Institution
MUSC
Recruitment Contact
Heather Ketchabaw
843-792-3738
ketchab@musc.edu

A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients with an Implantable Cardioverter Defibrillator + save

Date Added
January 8th, 2013
PRO Number
Pro00013791
Researcher
Robert Leman
Keywords
Cardiovascular
Summary

This study is comparing the experimental drug azimilide to placebo in patients with implantable cardioverter defibrillators (ICDs) to determine if it can reduce emergency department visits and hospitalizations. Azimilide is an antiarrhythmic drug, which means it is used to treat abnormal heart rhythms.

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