Clinical Research Directory

Salt-Sensitivity and Immunity Cell Activation

Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the normotensive population, and strong evidence indicates that reducing salt intake decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary salt contributes to blood pressure elevation, renal injury, and cardiovascular disease remains unclear. Our data indicated that monocytes exhibit salt sensitivity, and the investigators hypothesize that of salt sensitivity of these and similar immune cells correlate with the hypertensive response to salt intake. Currently, the research tools for diagnosing salt-sensitivity are costly, time consuming and laborious. In this study the investigators will identify monocyte salt-sensitivity as a marker of salt-sensitive hypertension.

Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study

Bioactive peptides derived from food proteins show potential for improving human health. One of such promising peptides is namely IRW made from egg white hydrolysate and composed of three peptides. This is a feasibility study to assess the acute effect of IRW in egg white hydrolysate for the management of high sugar and blood pressure. Participants at high risk of type 2 diabetes (T2D) or having T2D will undergo 4 consecutive treatments of 1 day each (randomly), during which they will consume a standardized breakfast with a smoothie containing different protein powders. Each treatment will be separated by a minimum of 1-week. Participants in the healthy control group will undergo 1 treatment only (one day).

A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Reducing Cardiovascular Risks: The Role of Alcohol Use

The purpose of this study is to learn whether avoiding alcohol can improve heart and blood vessel health in adults who regularly drink alcohol and have high blood pressure. High blood pressure is a major risk factor for cardiovascular disease (CVD), including heart attack and stroke. In this randomized, controlled trial, men and women aged 26 to 49 years who regularly consume alcohol and have high blood pressure will be assigned by chance to either stop drinking alcohol or continue their usual drinking habits for 8 weeks. Researchers will compare changes in blood pressure and other cardiovascular disease risk factors between the two groups. The information gained from this study may help researchers and health care providers better understand the effects of alcohol consumption on cardiovascular health and whether alcohol abstinence can reduce heart disease risk, especially in adults with high blood pressure.

Barber and Pharmacist Coordination to Improve Blood Pressure Management

The original, "Cut Your Pressure Too: The LA Barbershop Blood Pressure Study (LABBPS)" (NCT02321618) was a highly successful cluster-randomized trial of a community centered blood pressure (BP) reduction program focused on Non-Hispanic (NH) black men who experience the highest rates of hypertension (HTN) and its complications. Patrons of 52 barbershops in Los Angeles County were randomly assigned to either an intervention arm in which barbers encouraged meetings with trained clinical pharmacists who provided HTN treatment in the barbershops or a control arm in which barbers provided educational pamphlets on HTN and encouraged physician appointments. After 6 months, the intervention group had a statistically significant reduction in systolic BP (SBP) of 21.6 mmHg compared to the control group. Results were durable at 1 year. Thereafter, a pilot study (NCT03726710) aimed at improving the efficiency of the barbershop model of HTN care by substituting in-person visits with video visits once BP was at goal was undertaken in 10 hypertensive barbershop patrons. The intervention effect was unchanged. The current study represents Aim 3 of an NIH funded renewal application entitled, "Barber and Pharmacist Coordination to Improve Blood Pressure Management in Black Men." It will build upon the foundational work of the original study and telemedicine pilot by evaluating the efficacy of a fully remote hypertension management program.

Oura Blood Pressure Profile Study

The proposed study is designed as a prospective, single-arm, observational, non-significant risk device study to evaluate the performance of Oura's investigational Blood Pressure Profile algorithm in identifying signs of hypertension.

Can Changes in Dialysate Sodium Concentration Improve Blood Pressure and Endothelial Function in Chronic HD Patients?

People with end stage kidney disease cannot regulate salt and water normally, which often leads to high blood pressure, fluid overload, and a higher risk of heart disease. Hemodialysis is a life sustaining treatment that removes waste products, excess fluid, and electrolytes from the blood. However, the treatment itself can influence blood pressure and how the blood vessels function. Many patients experience symptoms such as thirst, headaches, fatigue, and swelling, which affect both daily well being and long term health. One possible way to reduce these problems may be as simple as adjusting the amount of sodium in the dialysis fluid. During dialysis, substances move between the patient's blood and the dialysate, the special fluid used in the machine. Sodium is one of the most important components because it helps regulate fluid balance and blood pressure. A higher sodium concentration in the dialysate can make patients feel more thirsty, cause them to drink more, and lead to fluid retention and higher blood pressure. On the other hand, lowering sodium too much can cause dizziness, low blood pressure, cramps, and discomfort during treatment. Because of this, there is ongoing debate about what the "right" sodium level should be. Too much sodium over time may also harm the blood vessels. The inner lining of the vessels, called the endothelium, is protected by a thin layer known as the glycocalyx. This layer helps prevent sodium from entering the vessel wall and supports the production of nitric oxide, a molecule that relaxes blood vessels and reduces inflammation. High salt exposure can damage the glycocalyx and reduce nitric oxide production, making the vessels stiffer and raising blood pressure. In dialysis patients, low nitric oxide levels are linked to worse outcomes and episodes of rising blood pressure during treatment. Some small studies suggest that lowering dialysate sodium can improve blood pressure and endothelial function, but larger studies have not shown clear effects on survival. This indicates that we still do not fully understand which patients benefit most or how sodium changes affect both physical and subjective symptoms. This study aims to fill these knowledge gaps by examining how a lower sodium concentration in the dialysate affects blood pressure, blood vessel function, fluid overload, inflammation, and patient reported symptoms. The goal is to provide new insights that could help tailor dialysis treatment to individual patients in a simple and cost effective way. The study will compare two sodium concentrations: a lower level (133 mmol/L) and the standard level used in many clinics (139 mmol/L). Twenty five patients receiving chronic in center hemodialysis will participate. Each patient will undergo both treatments for three weeks each, in random order, with a two week washout period in between. This crossover design allows each patient to serve as their own control, making it easier to detect meaningful differences. The main outcome is the difference in 24 hour systolic blood pressure between the two sodium levels. Secondary outcomes include changes in nitric oxide levels in the blood, measures of fluid overload using two different techniques, markers of inflammation, arterial stiffness, and patient reported symptoms such as thirst, fatigue, and overall well being. The study will also compare two methods for assessing fluid overload: bioimpedance spectroscopy and a newer carbon monoxide rebreathing technique. Blood pressure and arterial stiffness will be measured over 44 hours using a portable device. Blood samples will be collected to analyze nitric oxide, inflammatory markers, and sodium handling in red blood cells. Fluid status will be measured using both bioimpedance and the CO rebreathing method. Patients will complete a weekly questionnaire developed together with dialysis patients to capture their experiences and symptoms.

A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.

Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension

To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

Diagnosing Variable Primary Aldosteronism.

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Digital Education for Hypertension Management: Effects on Self-Care and Health Literacy

The goal of this clinical trial is to learn whether a digital education program can help people with high blood pressure (hypertension) manage their condition better. The program aims to improve self-care behaviors and health literacy by teaching participants how to use digital tools, follow healthy lifestyle habits, and take their medicines regularly. Researchers will compare two groups. One group will receive digital education that includes short videos, brochures, and podcasts about blood pressure control and how to use online health platforms such as e-Nabız (Turkey's national e-health system). The other group will not receive this education. Participants will attend two sessions during two weeks. The main questions are: Does digital education improve self-care and e-health literacy in people with hypertension? Does it help participants take their medicine as prescribed and maintain healthy habits such as diet and exercise?

Delta GREENS Food is Medicine Intervention

Mississippi is a place deeply rooted in cultural values, yet also a place where generations of communities have experienced persistent health challenges intertwined with poverty. This project focuses on Bolivar, Washington, and Sunflower, contiguous counties in the Delta that are designated as health disparity populations. Over 65% of the 100,000 residents are Black/African American and \~30% live at or below the poverty level. Obesity rates are high and the rate of diabetes is almost double the national average. Tufts University received a grant from the National Institute of Minority Health and Health Disparities to develop, test, and evaluate a Food is Medicine program in Mississippi. The Delta GREENS Food is Medicine (FIM) Project, is a collaborative project in Bolivar, Washington, and Sunflower counties in Mississippi. The intervention involves regularly distributed fruit and vegetable produce boxes as well as nutrition education materials to the intervention group. The control group will receive produce boxes later, after they complete study activities. The project's primary goal is to improve health outcomes by creating a FIM intervention. The Delta GREENS FIM Project aims to become a model for promoting nutrition security and management of chronic conditions in varied communities nationwide.

Home Blood Pressure Telemonitoring LINKED With Community Health Workers to Improve Blood Pressure

The LINKED-BP Program is a patient-centered, multi-level intervention linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo) that links with all Bluetooth-enabled validated blood pressure (BP) devices, support from community health workers (CHWs), and BP measurement training at community health centers serving high-risk adults to prevent stage 2 hypertension (BP ≥ 140/90 mm Hg). The LINKED-BP Program study will recruit a total of 600 adults (30 from each practice) with elevated BP (120-129/\<80 mm Hg) or untreated stage 1 hypertension (130-139/80-89 mm Hg) across 20 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors (HBPM) and will be managed by the patients' primary care clinicians as usual; and (2) the LINKED-BP Program or "intervention arm," which will include training of patients on HBPM, Sphygmo BP telemonitoring app, and CHW visits for education and counseling on lifestyle modification. The intervention period for each study participant is 12 months.

Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention

Expanding evidence-based interventions for hypertension and stroke prevention among youth and their caregivers is crucial for meeting World Health Organization and Nigerian health goals. Innovative strategies are urgently needed to address the burden of hypertension and stroke in Nigeria, aiming to involve local communities, bridge generational gaps, and reduce health disparities. This study aims to determine the effect of a music-inspired intervention and campaign (Music4Health) designed by the community on blood pressure, stroke preparedness and intentions, and uptake of the intervention among youth-caregiver dyads in Nigeria.

Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)

High blood pressure (BP) is a major public health concern, especially in low and middle income countries. High BP is a highly prevalent condition, and it is usually associated with diabetes mellitus. Both high BP and diabetes are risk factors for major cardiovascular events including cardiovascular death, acute myocardial infarction, stroke, unstable angina and heart failure. In addition, high BP is also related to cognitive decline. The OPTIMAL-DIABETES trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower systolic blood pressure (SBP) target will reduce the occurrence of major cardiovascular events in diabetic patients compared to the standard SBP target.

Polypill for Prevention of Cardiomyopathy

This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily. The study duration is 6 months, and participants will be randomized to either polypill therapy or simultaneous prescription of the individual drugs. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.

Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans

Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+). This trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks. This phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.

Cardiometabolic Risk in Pregnancy and Postpartum

The goal of this study is to evaluate changes in blood pressure and early cardiovascular risk markers and to determine whether a postpartum education intervention can improve cardiovascular risk monitoring among pregnant women in their third trimester through six months postpartum in Accra, Ghana. The study includes women aged 18 years and older with and without pregnancy-related cardiometabolic complications. Findings from this study will inform the development of scalable postpartum screening and intervention strategies to reduce long-term cardiovascular disease risk among women.

Evaluation of Superiority of Valsartan+Celecoxib+Metformin Over Metformin Alone in Type 2 Diabetes Patients

Evaluation of safety, tolerability and superiority of RK-01, a valsartan plus celecoxib dual add-on to metformin-HCL XR over metformin in newly diagnosed and obese adult type 2 diabetes patients with high blood pressure, arthritis and inadequate glycemic control with metformin monotherapy, diet and exercise over 26 weeks of treatment. Objective: To assess effect of RK-01 on HbA1c levels, beta cell function and insulin resistance with co-administration of valsartan, celecoxib and metformin-HCl XR relative to metformin monotherapy. Hypothesis: After 26 weeks of treatment with valsartan, celecoxib and metformin-HCl XR provides greater improvements in glycemic, inflammatory and atherogenic parameters compared to metformin monotherapy.

Produce Prescription for Healthy Blood Pressure

The investigators want to understand the effects of the Produce Prescription for Healthy Blood Pressure program on blood pressure control and people's health. The overall project goal is to improve blood pressure levels of West Dallas residents with high blood pressure through participation in this produce prescription program.

Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study

Rationale: Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure. The device has been validated using clinical trials in hospitals, but evaluation in the intended remote setting during treatment is lacking. Primary objective: To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs. Study population: A group, untreated or treated for hypertension, with uncontrolled BP and medical indication for antihypertensive drug treatment initiation, uptitration or change in antihypertensive drugs. Study design: Blood pressure will be measured by the investigative device and a reference device at pre-treatment and after 28 days. The investigative device is the Corsano CardioWatch 287-2, which measures blood pressure through optical photoplethysmography (PPG). The reference method involves automatic blood pressure cuff measurements. Main study parameters/endpoints: Absolute systolic and diastolic blood pressure decrease after change of treatment measured by the Corsano Cardiowatch 287-2 after 28 days, compared to automatic blood pressure cuff measurements.

The Impact of a Resistance Training Intervention on Blood Pressure Control in Older Adults With Sarcopenia

Current prevention and treatment of high blood pressure (BP) in sarcopenia, by non-pharmacological approaches remain limited and are far from optimal. This randomized control intervention pilot study will provide new evidence of the unexplored relationship between muscle strength and high BP in sarcopenia, and experimentally test the effects of an evidence-based progressive resistance training intervention on BP, while also examining reversibility to identify muscle strength as a non-pharmacological target for BP control in older sarcopenic adults.

Behavioral Economics Trial To Enhance Regulation of Blood Pressure (BETTER-BP)

BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure) is a phase II, single-center, prospective, pragmatic randomized clinical trial within the New York City Health and Hospitals (NYC-H+H) system and NYU Langone Family Health Centers. The trial will recruit from 3 NYC-H+H ambulatory clinics as well as NYU Langone Family Health Centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. The trial will randomize 435 patients with hypertension determined to have poor adherence (\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. Baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.