Clinical Research Directory

The BASIC-S Feasibility Study for Vascular Risk Reduction

Vascular risk factors drive stroke, heart disease, and dementia, but translating lifestyle guidelines into routine clinical care remains challenging. To address this, we developed BASIC-S (Blood Pressure, Activity, Sleep, Interaction, Consumption, and Support), a framework targeting Blood pressure, Activity, Sleep, Interaction (socially), Consumption (nutrition), and Support using partner support and motivational interviewing. This individual-focused approach bypasses the logistical and financial barriers of complex clinical interventions by using sustained behavioral science to support gradual lifestyle changes. This study is a single-center, mixed-methods, cluster-randomized pilot trial evaluating the feasibility of the BASIC-S protocol in an occupational setting. A maximum of 60 households (120 participants) will be randomized 1:1 to either the BASIC-S intervention (motivational coaching, secure video check-ins, automated text messages, and a digital workbook) or standard care. Outcomes will assess feasibility, acceptability, and the validity of new tracking metrics to inform a future full-scale trial.

Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake/Asleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.

Impact of Online Medical Misinformation

A cross-sectional analytical study was conducted among adult patients diagnosed with chronic diseases to assess the impact of online medical misinformation on medication adherence, treatment decision-making, and health care-seeking behavior.

Study of the Progression of Chronic Cardiovascular Conditions

This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health

The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.

Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension

To evaluate both sides of the common carotid artery, renal artery, and femoral artery in Hypertension patient that cause of systemic arterial hypertension and/or the effects of target organ damage, both structural and functional markers.

Navigating Hypertension and Food Insecurity

This multi-site randomized controlled trial uses a community-based approach to evaluate a Food as Medicine program for Native Hawaiian and Pacific Islander (NHPI) adults in Hawaii who have high blood pressure and difficulty affording healthy food. The study has two main goals: (1) to implement a produce prescription program and see if adding personal support from Community Health Workers (CHW) improves blood pressure among other health outcomes, and (2) to determine the program's cost-effectiveness. The study will take place across three Federally Qualified Health Centers in Hawaii. Produce prescription program participants at each site will receive $100 per month, either in the form of produce boxes or monthly vouchers to purchase fruits and vegetables, for 12 months (totaling $1200). In past studies, personal challenges (e.g., lack of transportation, lack of cooking skills) have made it difficult for participants to use the vouchers and/or the purchased produce. In other food as medicine interventions, participants have similarly faced various personal, social, and environmental barriers that limit the program's efficacy. To help participants navigate through these challenges, the investigators want to test adding 1-on-1 support from a CHW throughout the program. Other studies have found that health interventions delivered by CHWs have been effective in reducing blood pressure, blood glucose and weight, especially among vulnerable populations, such as NHPIs and those with food insecurity. The CHWs in this study will receive a training using a curriculum tailored specifically to their community and that is in alignment with the Pilinahā: The Four Connections Framework, which focuses on key connections that Indigenous people seek to attain health and can be employed to overcome health disparities. To test the effectiveness of the added CHW support, there will be two groups of participants: Group 1 (Intervention) will receive the monthly produce prescription ($100 vouchers or produce box) plus meet with a CHW every two months for support with program challenges. Group 2 (Control) will receive the same monthly produce prescription, but will not have meetings with a CHW. The investigators want to see if the added support from CHWs leads to better blood pressure results, among other health outcomes. Upon providing informed consent and enrolling into the program, produce prescription program participants will: * Attend 5 study visits over the one year program. These happen at the start, and then at 3, 6, 9, and 12 months. * Complete health checks at the first visit. This includes getting a home blood pressure monitor and learning about heart health and nutrition. Staff will measure height, weight, waist size, and blood pressure. * Answer surveys about their demographic background, health habits, diet, and culture. * Receive $100 in vouchers every month for 12 months to redeem for fruits and vegetables at a local retailer. * Group 1 will additionally meet with a CHW every two months for 1-on-1 support with any challenges related to the program. * Group 2 will receive monthly reminders to use their vouchers but no CHW meetings. After the program ends, researchers will analyze the financial value of the intervention. This involves calculating the total cost to run the program (including vouchers, CHW training and salaries, and administrative costs) and comparing it to potential savings in healthcare costs. By looking at improvements in blood pressure, researchers can estimate how many heart-related health problems were prevented and how much money was saved on medical care.

Feasibility and Acceptability of Isometric Exercise and Lifestyle Change for the Management of Hypertension

High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure. Participants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device. Upon completion of the study, participants will be interviewed to gather their views and opinions on the programme. Changes in blood pressure will be evaluated at 12 and 24 weeks. By exploring whether lifestyle advice and an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.

Mortality Outcome of Controlled Blood Pressure Participants

Despite advances in antihypertensive therapy, some patients with well-controlled blood pressure still experience fatal outcomes. This paradox raises critical questions about the efficacy of blood pressure-targeted interventions and whether BP control alone ensures survival. This systematic review and meta-analysis aims to evaluate all-cause mortality and cardiovascular death among hypertensive patients who achieved BP targets in RCTs or open-label trials. To determine whether achieving controlled blood pressure through intentional intervention (pharmacological or procedural) in RCTs or open-label studies reduces mortality (all-cause and cardiovascular) in hypertensive patients.

Syntrillo Telehealth Stroke Risk Reduction Study

A prospective, single-arm, open-label study evaluating the impact of Syntrillo's telehealth program on stroke risk factors, particularly blood pressure, among 68 high-risk patients. The 6-month intervention includes personalized remote care with blood pressure monitoring, wearable tracking, and multidisciplinary telehealth visits.

An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.

The purpose of this extension study is to collect additional safety and efficacy on QCZ484 for hypertensive patients who successfully completed the parent study, CQCZ484A12201 or additional QCZ484 studies as specified in the respective parent study protocols.

Mobile Health Program for Post-Preeclampsia Hypertension

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control

The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework. Participants will be randomized 1:1 to FIM+DASH or usual-care control. The 24-week trial includes a 12-week FIM+DASH intervention followed by a 12-week maintenance period and leverages existing partnerships with community-based organizations for home food delivery and culinary skill-skill building. The main questions it aims to answer are: (1) What is the effect of FIM+DASH vs. usual care control on blood pressure? (2) What is the effect of FIM+DASH vs. usual care control on DASH diet adherence (diet quality), body weight, and waist circumference? (3) How to identify factors associated with the sustainability and scalability of FIM+DASH in real-world settings?

Project HOPE (Hypertension Outreach Through Partnership and Engagement)

The goal of this study is to learn if a nurse-led, task-shifting, community-based program can help lower blood pressure in adults aged 25 and older with uncontrolled high blood pressure (hypertension) in Monrovia, Liberia. The program is delivered through community-based mobile clinics by community health nurses (CHNs) trained in WHO-aligned hypertension care within the Ministry of Health's (MOH) Community Health hypertension management protocols. Participants will: * Receive blood pressure treatment from trained community health nurses (CHNs) at community-based mobile clinics in their communities, including medication and lifestyle counseling. * Complete surveys at their first visit, at 4 to 6 weeks, and at 3 months about their experience, satisfaction, and medication use. * Attend follow-up visits at the mobile clinic based on their blood pressure levels. Community health nurses delivering the program will complete structured training and be invited to complete surveys before and after training, and to take part in interviews about their experience at the end of the study. The study will take place over 7 months in five high-thoroughfare communities in Monrovia, Liberia, and aims to enroll 150 participants.

IMPACT-HTN Study of Patients With Hypertension

An estimated 120 million people have high blood pressure (hypertension) in the US, of which approximately 10% have resistant hypertension. This study aims to enroll patients who continue to have hypertension while being treated with at least two medications. The study will follow patients for approximately 3 months and collect real-world information on changes in their health to identify an ideal patient profile that would benefit from 4th-line antihypertensive therapies, including, but not limited to, FDA-approved aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.

University of Georgia Mind Your Heart Pilot Study

The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are: 1. Does participation in a 6-week nutrition education program improve dietary behaviors? 2. Does participation in the program improve health measures such as blood lipids, blood pressure, and eye nutrient levels? Participants will: 1. Visit the Institute of Gerontology at the beginning and end of the 6-week study for: * Blood draws to measure blood lipids (e.g., cholesterol) * Blood pressure measurement * Eye exams to assess nutrient levels * Completion of questionnaires about dietary habits 2. Complete online questionnaires before and after the study period 3. Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)

Usefulness of the VExUS Protocol for Dry-Weight Adjustment in Hemodialysis Patients: The Multicenter VExHD Study

The objective of this prospective observational study is to determine the utility of ultrasonographic assessment using the VExUS protocol for dry weight adjustment in clinically euvolemic patients undergoing hemodialysis. The primary hypothesis is that the assessment of venous congestion by ultrasound may help identify patients who can tolerate increased ultrafiltration, thereby improving blood pressure control. The comparison group will consist of patients who do not meet the criteria for venous congestion according to the VExUS protocol. In patients meeting the criteria for venous congestion, the ultrafiltration volume during hemodialysis will be increased.

To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyle Program With Components of Social Determinants of Health Activities in Real-world Settings (Clinical and Non-clinical Settings) Across 3 Years

In this study, the investigators are conducting a Type 3 hybrid effectiveness-implementation trial to evaluate the implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 400 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The aims of this study are threefold: 1. To evaluate the implementation of the PPP across multiple community sites using a Type 3 hybrid effectiveness-implementation design guided by established frameworks such as RE-AIM and PRISM. 2. To examine participant-level outcomes associated with PPP implementation, including changes in cardiometabolic risk factors, health behaviors, and SDOH factors from baseline to 3 and 9-month follow-up. 3. To evaluate the cost and cost-effectiveness of implementing the PPP across community settings.

RUSH Food is Medicine Veggie Rx - GusNIP Produce Prescription

The goal of this clinical trial is to assess nutrition incentives and produce vouchers to measure the impacts of food insecurity-related chronic health conditions in adults with hypertension and/or diabetes. The main questions it aims to answer are: * Does participation increase fruit and vegetable consumption for participants? * Does participation reduce individual and household food insecurity? * Does participation reduce healthcare utilization and associated costs? * Does participation lead to improvements in diet-related health outcomes (e.g., hypertension, diabetes)? * Does participation support the local economy by increasing participant spending at local food vendors? Participants will: * Receive 6 months home delivered produce prescription boxes * Receive 6 months match of produce vouchers * Receive nutrition education and participate in Chronic Disease Self-Management classes

Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks

To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions \[nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer). The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)

QLS1410 in Participants With Uncontrolled Hypertension

The goal of this clinical trial is to measure the efficacy and safety of QLS1410 in participants with uncontrolled hypertension (uHTN) or treatment-resistant hypertension (rHTN). The main objective is to compare the difference in systolic blood pressure（SBP) change from baseline at Week 12 of treatment between participants receiving QLS1410 tablets and participants receiving placebo tablets.

Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction

This is an open-label pilot study to evaluate the feasibility of Cardiac Neuromodulation Therapy (CNT) in patients with high blood pressure and heart failure who require dual-chamber pacemaker implantation or replacement. The study will assess blood pressure and heart function at rest and during exercise, with and without CNT, for up to 12 months. Participants will receive the Moderato Plus device and complete scheduled follow-up visits. After study completion, CNT therapy will be discontinued and participants will return to standard medical care.

Hemodynamic Effects of Lithotomy Position in Surgical Patients (PH-LITHO)

Anesthesia-induced hypotension is a common occurrence in elderly hypertensive patients and is closely associated with increased postoperative morbidity * This study aims to investigate whether the lithotomy position, a non-pharmacological and cost-free approach, can reduce the incidence of post-induction hypotension (PIH) in this high-risk population by increasing venous return Sixty patients aged 65-80 with a history of hypertension were randomly assigned to either the Supine Group (Group S) or the Lithotomy Group (Group L) * In Group L, patients were placed in the lithotomy position 120 seconds before the start of anesthesia induction * Blood pressure was monitored every minute for the first five minutes following induction * The study evaluates whether this simple positioning strategy can maintain hemodynamic stability, reduce the drop in mean arterial pressure, and decrease the overall need for vasopressor medications like ephedrine

Out-of-office Monitoring for Rhythms Of Normal Versus Atrial Fibrillation

The goal of this clinical trial is to learn if screening for atrial fibrillation (AFib), a common irregular heart rhythm, through daily home blood pressure monitoring will decrease the time to atrial fibrillation diagnosis in older adults with hypertension. The main question it aims to answer is: \-- Does introducing screening for AFib using a blood pressure monitor with AFib detection technology decrease time to AFib diagnosis in patients with high blood pressure, compared to usual care using a conventional home blood pressure monitor with no AFib detection? Participants will participate in two phases of the study: (1) clinical trial and (2) the registry. During the 6-month clinical trial period, participants will be asked to: * Take blood pressure measurements twice daily * Answer short weekly mobile app-based surveys * If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test During the 12-month registry period, participants will be asked to: * Take blood pressure measurements twice daily * Answer monthly mobile app-based surveys Researchers will compare standard blood pressure measurements and AFib screening blood pressure measurements to see if there is a difference in the time to AFib diagnosis and other cardiovascular events. Participants will participate in two phases of the study: (1) trial and (2) the registry. During the 6-month trial period, participants will be asked to: * Take daily blood pressure measurements * Answer short weekly mobile app-based surveys * If assigned, complete continuous heart monitoring for 2 weeks and complete 1 blood test During the 12-month registry period, participants will be asked to: * Take daily blood pressure measurements * Answer monthly mobile app-based surveys