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.
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.
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.
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.).
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.
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.
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.
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.
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.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.