A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension Save

Date Added
September 24th, 2019
PRO Number
Pro00091232
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.

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

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure Save

Date Added
November 13th, 2018
PRO Number
Pro00083036
Researcher
Sheldon Litwin

List of Studies

Silhouette
Keywords
Diabetes, Heart, Hypertension/ High Blood Pressure
Summary

Volunteers are being asked to participate in a clinical research study to find out if the drug dapagliflozin is safe and effective compared to placebo (an inactive substance) in the treatment of people with heart failure with preserved ejection fraction (ability of the heart to relax and squeeze to pump out blood). AstraZeneca is doing this research to find out if the new medication called dapagliflozin will work and be safe for the treatment of heart failure in addition to standard therapy used for treatment of heart failure. The study is planned to go on for about 33 months and include 4700 patients from about 21 countries.

This research study is carried out to see if dapagliflozin is effective in preventing worsening of heart failure and improving survival in patients with heart failure and preserved systolic function. The placebo tablet will look identical with the dapagliflozin tablet. During the study participants will either receive dapagliflozin 10 mg once a day or an identical-looking placebo once a day. Which study drug subjects will receive throughout the study is decided at random by a computer (purely by chance, like the tossing of a coin). Subjects have a 50% chance of receiving dapagliflozin and a 50% chance of receiving placebo. Subjects and the study doctor will not know which study drug the participants receive.

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

Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett

List of Studies

Silhouette
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@musc.edu

The "RADIANCE II" Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension Save

Date Added
October 9th, 2018
PRO Number
Pro00081841
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the FDA. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries). The ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels.

Participants will stop taking hypertensive medication before the procedure and up to two months after the procedure. Participants will be randomized to the procedure or control and will be followed for 36 months. At the six month follow-up appointment, participants will learn whether they had the procedure or not. Those who did not receive the procedure can opt in to have the procedure in the future.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
8438765009
paladugc@musc.edu

Using Portable Telemedicine to Connect homebound patients to medical and social resources (Connected Home) Save

Date Added
September 19th, 2018
PRO Number
Pro00078976
Researcher
Gayenell Magwood

List of Studies


Profiles_link
Keywords
Diabetes, Hypertension/ High Blood Pressure
Summary

This is a research study to find out how acceptable and how to deliver a Home Care Tele-Visits with adults diagnosed with Diabetes Mellitus (Diabetes) and/or Hypertension (high blood pressure). This study will consist of three at home visits with a Medical Tele-Assistant. Each visit will be scheduled to accommodate the participant's schedule and will be about 2-3 weeks apart. During the 2nd and 3rd visit the participant will able to use mobile technology to visit with their doctor and community/social resources (family member or friend). Participants will not be expected to pay for these in-home visits, and will be compensated for their time and participation.

This study is a pilot project, meaning that the goal is to gather data about how easily technology can be used in the home to provide access to health care providers, and social/community resources. Participants may benefit from participating in this study, but that cannot be guaranteed. There are minimal risks associated with participating in this study, such as a loss of privacy while using the Telemedicine System.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-5032
slans@musc.edu

Immune response to pneumococcal vaccination in aging renal transplant recipients Save

Date Added
June 19th, 2018
PRO Number
Pro00077548
Researcher
Maria anna Westerink

List of Studies

Silhouette
Keywords
Aging, Diabetes, Geriatrics, Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Immune System, Kidney, Transplant, Vaccine
Summary

We will study how well the relatively new FDA approved pneumonia vaccine can protect older renal transplant recipients against pneumococcal illness. We will specifically study the group of renal transplants in whom the cause of renal failure was either diabetes mellitus II and/or hyoertension. We will compare the findings against those we find in younger renal transplant recipients, older healthy individuals and older persons with diabetes but normal kidney function. Healthy younger individuals will serve as controls for optimal vaccine response.

Institution
MUSC
Recruitment Contact
Myroslawa Happe
843-792-2218
soloshch@musc.edu

Improving Healthy Outcomes through Fresh Food Access Save

Date Added
April 18th, 2018
PRO Number
Pro00073034
Researcher
Mark Humphrey

List of Studies

Keywords
Diabetes, Hypertension/ High Blood Pressure, Nutrition, Obesity
Summary

The proposed project recognizes the relationship between food insecurity and social determinants of health. By developing a strong clinic/organization linkage between specific Palmetto Health clinics and FoodShare, we will be able to determine if increasing access to fresh produce through an every other week produce box, participation in cooking classes, and clinician reinforcement improves health outcomes for patients who are identified as food insecure.

Institution
Palmetto
Recruitment Contact
Beverly Wilson
803-665-7800
beverly.wilson@uscmed.sc.edu

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor Save

Date Added
March 27th, 2018
PRO Number
Pro00070627
Researcher
Ashley Wabnitz

List of Studies

Silhouette
Keywords
Hypertension/ High Blood Pressure, Stroke
Summary

This racial disparity in stroke is more prominent in the Southeastern region of the US, where 3 states have long been recognized as representing the ?buckle' of a ?stroke belt'. One of these 3 states is South Carolina, where our proposed study will take place. Stroke (including recurrent stroke) is highly preventable via control of high blood pressure. Mobile health (mHealth) technology may offer a promising approach for enhancing blood pressure control after stroke. mHealth tools provide an easy-to-use self-management system that permits optimal medication adherence. PACESETTER will conduct an implementation trial of the intervention
(personalized phone text messaging and home BP monitoring) vs. usual care in 200 recent stroke patients with HTN recruited across the three main safety net hospitals in the state of SC. The project will explore whether the intervention vs. standard care is associated with a reduction in cardiovascular event-related emergency department encounters and re-hospitalizations within 12 months and whether the intervention has potential to reduce vascular events.

Institution
MUSC
Recruitment Contact
deleted
TBD
TBD

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

List of Studies

Silhouette
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

Diabetes, modified lipoproteins, and preeclampsia Save

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

List of Studies

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

Change_preferences

-- OR --

Create_login