The Effect of Congenital Heart Disease on Employment, Neuropsychological Outcomes, and Quality of Life in Adults with Down Syndrome Save

Date Added
August 13th, 2019
PRO Number
Pro00090744
Researcher
Stephanie Gaydos

List of Studies

Keywords
Cardiovascular, Memory Loss
Summary

The proposed study will investigate the effect of congenital heart disease (CHD) on rates of employment, community participation, neuro-psychological comorbidities, and quality of life (QOL) in adults with Down syndrome. Knowledge of these longitudinal functional outcomes may assist clinician guidance to families and highlight needs for specific resources and interventions to achieve optimal outcomes in adulthood.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
2-1213
choudhar@musc.edu

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy Save

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies

Silhouette
Keywords
Body Composition, Cardiovascular, Drug Studies, Healthy Volunteer Studies, HIV / AIDS, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

Management of Patients Presenting with Acute Chest Pain Following Coronary Computed Tomography Angiography Save

Date Added
July 9th, 2019
PRO Number
Pro00087460
Researcher
Uwe o.p. Schoepf

List of Studies


Profiles_link
Keywords
Cardiovascular, Coronary Artery Disease
Summary

Patients who present to MUSC's Chest Pain Center with acute chest pain and have undergone coronary computerized tomography angiography or triple rule-out computed tomography imaging showing an intermediate stenosis will be prospectively selected. Consented patients will then have their clinical indicated coronary computerized tomography angiography or triple rule-out computed tomography imaging undergo an expedited computed tomography-fractional flow reserve analysis analysis. This analysis will be provided to Chest Pain Center physician of record to aid in downstream patient treatment decision making. Patients will then be followed-up at 3-months via telephone call and electronic medical records review.

Institution
MUSC
Recruitment Contact
Dante Giovagnoli
8438764922
giovagnd@musc.edu

SURVEILLANCE HEARTCARE® OUTCOMES REGISTRY (SHORE) Save

Date Added
June 19th, 2019
PRO Number
Pro00086580
Researcher
Adrian Van Bakel

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this registry is to observe outcomes of heart transplant recipients who are managed with HeartCare. This is done by collecting information about the participant's heart transplant such as test results, biopsy results, and outcomes, storing that information in a database, and using that information for research. HeartCare is a combination of two tests from one blood draw. One test, AlloMap®, is a well-established test for heart transplant recipients. The other test, AlloSure-Heart, is a new test that directly measures injury of the transplanted heart. HeartCare provides the results of both tests for a noninvasive assessment at time of testing. The registry will be active for up to 5 years after enrollment.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophgeal Echocardiography for Transcatheter Aortic Valve Replacement Save

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Profiles_link
Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

Institution
MUSC
Recruitment Contact
Christine Aanstoos
8437921869
aanstoos@musc.edu

ECG Belt for CRT Response (ECG Belt) Save

Date Added
May 19th, 2019
PRO Number
Pro00085400
Researcher
Michael Field

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to compare the management of CRT device patients using the Medtronic ECG Belt Research System and using routine hospital practice. The participant will be assigned (randomized) to one of 3 study groups. The ECG Belt Research System will be used for data collection at Post-Implant follow-up, 6 months, and 9 months for all groups, in addition to the following:

? Group 1 ? About 200 subjects will be in this group. If participant is in Group 1, he/she will have an ECG Belt guided implant procedure. The ECG Belt Research System will be used to help with the programming of device at Post-Implant follow-up and the 6 month visit.
? Group 2 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at your post-implant follow-up visit. It will be used to help with the programming of device at the 6 month visit.
? Group 3 ? About 100 subjects will be in this group. Participant will have a routine implant procedure. The ECG Belt Research System will be used in blinded mode at the post-implant follow-up visit and 6-month visit.

The ECG Belt Research System is investigational because it is not approved to be used outside of a study. The experimental procedures in this study are: The ECG Belt guided implant procedure and optimizing CRT settings using the ECG Belt Research System.

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

Pulmonary Hemodynamics during Exercise - Research Network Save

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of SOtagLiflozin on Clinical Outcomes in HemOdynamIcally STable Patients with Type 2 Diabetes POST Worsening Heart Failure Save

Date Added
May 14th, 2019
PRO Number
Pro00082460
Researcher
Bhavadharini Ramu

List of Studies

Silhouette
Keywords
Cardiovascular, Diabetes
Summary

Sotagliflozin (SAR439954) is a medicine you take by mouth that is being developed by Sanofi for the potential treatment of type 2 diabetes (T2DM). Sotagliflozin is an "investigational drug". The purpose of the study is to show that sotagliflozin can decrease the risk of cardiovascular death, or decreases the risk of being hospitalized for heart failure. Furthermore, the study will observe whether sotagliflozin reduces the risk of kidney disease, or if sotagliflozin could lead to changes in the way you use other medications. The study will last about 3 years and involve about 4000 participants. The Study has 3 main periods, as follows: Screening, a Double-Blind Treatment period, and a Follow-Up period.

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

A Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure and Preserved Left Ventricular Ejection Fraction (PHHFpEF) Save

Date Added
March 25th, 2019
PRO Number
Pro00085482
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF.

This study compares an active drug to a placebo. The participant will receive either the active drug, levosimendan, or a placebo via a 24 hour infusion. The study will take place over 6 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-8300
hinsone@musc.edu

An Open-Label Rollover Study of Levosimendan in Patients with Pulmonary Hypertension with Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF) Save

Date Added
March 20th, 2019
PRO Number
Pro00086421
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Cardiovascular
Summary

The purpose of this study is to find out if levosimendan is safe and effective in improving symptoms and outcomes for patients with PH-HFpEF who have previously participated in the TNX-LVO-04 study. All patients who are enrolled in this study will receive levosimendan weekly through a 24 hour infusion at their home. Office visits will occur at weeks 3, 6, 12, 24, 48, and final visit.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-5935
hinsone@musc.edu

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