Disparities in Hypertension Risk Among Young Adults: The Role of Epigenetics

Date Added
November 2nd, 2020
PRO Number
Pro00100786
Researcher
Joy Jones Buie

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

This clinical research study is being done to evaluate the association between hypertension risks and mental stress in a diverse population of college students. We will measure blood vessel stiffness. Participants will fill out questionnaires about stress, lifestyle, behaviors and demographics. We will see if measures of blood 000 vessel stiffness are associated with markers of mental stress in healthy college students between the ages of 18 and 24 years. The study lasts a maximum of two weeks, with the first study visit being 120 minutes and the second study visit being 90 minutes.

Institution
MUSC
Recruitment Contact
Joy Buie
843-792-6098
jonejn@musc.edu

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial (NanoSense)

Date Added
April 28th, 2020
PRO Number
Pro00098518
Researcher
Adrian Van Bakel

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is being done to find out if we can better monitor subjects with heart failure with the use of a wearable device (called SimpleSense garment) that can monitor multiple factors of heart failure that affect the body such as heart rate, activity, heart rhythm, and respiratory rate. Participants will wear the SimpleSense garment for 90 days for at least 12 hours daily. Participation in the study will include two research clinic visits and 2 phone calls over 4 months. Participants will be compensated for time and travel.

Risks of this study include loss of confidentiality, blood draw and skin irritation from wearing the garment.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-876-5873
johnjacq@musc.edu

RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

Date Added
January 14th, 2020
PRO Number
Pro00095660
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of the study is to evaluate the safety and how well the V-Wave Interatrial Shunt works. The study will also look at information obtained from the tests performed to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 1 year to up to 7 years depending on randomization group. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks. There will be a minimum of 10 or up to 15 planned research clinic visits. Subjects will have 1 overnight hospital stay for the study related RHC and research procedure. Each participant will receive a phone call between all study visits.

Subjects will have a 50:50 chance of receiving the Shunt during the randomization procedure (like the flip of a coin). Neither the subject, nor the blinded study doctor or blinded study coordinator will know which group subjects are in. Participants will be randomized to either the treatment group (and receive the Shunt) or the control group (and not receive the shunt). Neither the subject nor the study doctor will decide what group subjects are assigned.

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

Characterization of patient-, provider-, and clinic-level factors associated with implementation, clinical outcomes, and sustainability of diabetes remote patient monitoring

Date Added
January 3rd, 2020
PRO Number
Pro00094517
Researcher
Elizabeth Kirkland

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Minorities
Summary

The purpose of this formative research is to explore and understand patient-, provider-, and systems-level characteristics that affect the sustainability and success of remote patient monitoring technology applied to diabetes chronic care. This will be completed through evaluation and analysis of the Technology Assisted Case Management in Low Income Adults with Type 2 Diabetes (TACM-2) implementation program. TACM-2 utilizes remote patient monitoring (RPM) of diabetes and hypertension to augment regular clinical care, with the ultimate goal of improving health outcomes particularly for low-income patients regardless of geographic location.

This exploratory study's broad goal is to characterize key barriers and facilitators to RPM use over time through a mixed methods design. We will utilize data gathered as part of an ongoing quality improvement program, TACM-2, to provide quantitative data on RPM uptake and effectiveness. We will also obtain qualitative and quantitative data from participating patients and healthcare teams. Our objectives are to assess:
1) patient-level variables that are associated with sustained device use and clinical outcomes over time,
2) patterns of device uptake and data transmission across South Carolina as markers of scalability and sustainability, and
3) patient-, clinic- and system-level barriers and facilitators of RPM implementation.

Institution
MUSC
Recruitment Contact
Ryan Kruis
843-792-4703
kruis@musc.edu

Reducing Disparities in Living Donation Among African Americans

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek DuBay

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

Community Navigation to Address Hypertension Management in Rural Belize

Date Added
December 6th, 2019
PRO Number
Pro00093670
Researcher
Jessica Chandler

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

We will conduct key informant interviews (KII) with a diverse group of healthcare administrators, healthcare providers, community healthcare workers and patients/caregivers. The purpose of these KIIs is to 1.) inform the development of a hypertension management intervention and training materials adapted for cultural and contextual relevance, and 2.) the optimal research design for future, larger-scaled, multi-village interventions. We will conduct up to 30 interviews including up to 15 administrators/clinical team members including community health care workers and 15 patients until we reach thematic saturation.
The administrator and clinician interviews will query structures and processes currently in place for diagnosing and managing hypertension in rural Belizean adults. Additionally, we will inquire about barriers and facilitators regarding medication management for hypertension, perceptions of caring and follow-up, patients' needs and wants related to care from their physicians. We will also include questions and discussions regarding clinicians' preferences for hypertension management and frequency and format of patient data delivery from the community health care workers.
Patient interviews will query current hypertension management strategies including self –reported medication adherence estimations, education and support needed, quality of current care model, and suggestions/insight into best approaches for utilizing the navigators (e.g., where best to centrally station them in the community, how often to send navigators, best/worst times of days, etc.).

Institution
MUSC
Recruitment Contact
Luke Sox
843-792-9500
soxl@musc.edu

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

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

List of Studies


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

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

List of Studies


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

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

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

List of Studies


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

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

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

List of Studies


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 two of 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
Ariana Tinker
8437926881
tinkera@musc.edu



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