Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure

Date Added
April 11th, 2023
PRO Number
Pro00126551
Researcher
Sheldon Litwin

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure, Shortness of Breath
Summary

The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the Inter Atrial Shunt Device (IASD) in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. This study involves the use of an investigational medical device called the Corvia Atrial Shunt (CAS) System. The CAS is permanently implanted in the heart to reduce the increased pressure in the left side of the heart by creating a small opening between the two upper chambers of the heart. Participants will have a 50% chance of being in either group A having the CAS placed or group B and not receiving the device. Subjects will have 7 research clinic visits, and multiple telephone calls for a total of 5 years of follow-up. The research clinic visits will include medical exams, health questionnaires, ECG and echocardiogram of the heart and 6 minute hall walk tests.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

Clinical evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for renal denervation in patients with uncontrolled stage 2 hypertension

Date Added
March 14th, 2023
PRO Number
Pro00126807
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

This study is seeking participants with uncontrolled high blood pressure despite taking blood pressure medications. The study is examining an investigational device, meaning not approved for commercial use or sale by the Food and Drug Administration (FDA), called the TIVUS System. TIVUS, or Therapeutic IntraVascular UltraSound (TIVUS™) System, is designed to denervate (deaden) the nerves surrounding the renal arteries (blood vessels going to the kidneys) as a way to help lower blood pressure. Participation in this study will last three years and involve approximately 11 in person visits and 3-4 telehealth visits. Study related procedures include blood pressure monitoring both in clinic and at home, 24 hour ambulatory blood pressure monitoring, questionnaires, blood work, electrocardiogram (ECG), which is a recording of the electrical activity of your heart, CT scan of your kidneys and blood vessels around your kidneys and the renal denervation procedure. Some of the risks include bruising, bleeding, pain or damage to the renal arteries.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

Synergistic Interplay of Systemic Lupus Erythematosus (SLE) and Hypertension (HTN)

Date Added
January 13th, 2023
PRO Number
Pro00122811
Researcher
Justin Van Beusecum

List of Studies

Keywords
Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Lupus, Women's Health
Summary

This study is to explore the relationship between lupus and hypertension (high blood pressure). Female volunteers between the ages of 18-65 are needed who meet 1 of 4 possible participation types: 1. Participants with diagnosis of lupus and hypertension, 2.Participants with lupus without hypertension, 3.Participants without lupus but have hypertension, or 4. Participants that have no lupus diagnosis or hypertension.

Study participation includes a 1 time visit to the Research Nexus and involves a review of currently available medical records and a brief participant questionnaire specific to demographics and behaviors. The study visit includes a series of 3 blood pressure readings and a blood collection of approximately 2 tablespoons of blood. Compensation is available.

Institution
MUSC
Recruitment Contact
Jonathan Flume
843-792-3926
jof63@musc.edu

A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock

Date Added
December 7th, 2022
PRO Number
Pro00122530
Researcher
Blaithin McMahon

List of Studies


Keywords
Blood Disorders, Hypertension/ High Blood Pressure, Infectious Diseases, Kidney
Summary

The purpose of this study is to compare the safety and efficacy of the PMX cartridge ( Toramyxin) (in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock:
Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all subjects in whom treatment has been initiated, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
843-792-8166
pregulma@musc.edu

REAL Answers (Registry Expansion Analysis to Learn Answers)

Date Added
November 16th, 2022
PRO Number
Pro00124358
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, co-morbidities) and laboratory results. The 150 patients (or 1200 among the 8 sites) will be selected from both MUSC adult and pediatric SCD clinics starting at 12 years of age; those not previously enrolled in the SCDIC National Registry will be offered the possibility to enroll in SCDIC-II.
We will look at the following:
1- Compare the effect of new SCD medications – crizanlizumab, voxelotor, and L-glutamine – on clinical outcomes in individuals with SCD.
2 - Identify genetic and genomic predictors of response to crizanlizumab, voxelotor, and L-glutamine
3 - Integrate study data into the CureSCi metadata catalog (MDC) to enhance future cross-study analyses.

Institution
MUSC
Recruitment Contact
Jayla Moss
843-792-4653
mossjay@musc.edu

Sickle Cell Disease Patient Registry

Date Added
August 23rd, 2022
PRO Number
Pro00122740
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, comorbidities) and laboratory results. The SCDIC-II Registry will continue follow-up of this patient cohort and enroll new patients of all ages to enrich the data resource as a natural history study.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-876-8652
bourne@musc.edu

Early Feasibility Study of the Edwards APTURE transcatheter shunt system (ALT-FLOW US)

Date Added
April 26th, 2022
PRO Number
Pro00119538
Researcher
Brian Houston

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This is an early feasibility study to evaluate initial safety, device practicality, and performance of the Edwards APTURE Transcatheter Atrial Shunt System (study device) in subjects with heart failure. The Edwards APTURE Transcatheter Atrial Shunt System is intended for transcatheter treatment of symptomatic left heart failure patients. The Atrial Shunt opens a channel for blood to flow from the higher pressure left atrium to the lower pressure right atrium via the coronary sinus.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and implant procedure. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by heart failure.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu