Clinical Research Directory

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

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.

Low Energy Availability and Hypertension in Division I HBCU Athletes

Low energy availability (LEA) occurs when the body does not get enough calories to support both daily life and exercise. This can happen when athletes train hard but do not eat enough to match their energy needs. In both 2012 and 2023, the International Olympic Committee on Sports Nutrition recognized LEA as an important factor that can increase the risk of cardiometabolic disease (CMD), which includes conditions like high blood pressure, diabetes, and heart disease. LEA can affect many systems in the body. It may disrupt hormones (such as menstrual cycles), cause changes in blood sugar and cholesterol levels, weaken bones, impair digestion, and negatively impact mental health. Over time, these changes may be linked to chronic inflammation, which plays a key role in the development of disease. Maintaining proper energy balance can be especially challenging for athletes because they often train at levels well above general health recommendations. As a result, even highly fit athletes may unintentionally remain in a calorie deficit. Our recent pilot research found a significant relationship between LEA and high blood pressure in Black Division I collegiate athletes. This is important because this group has historically been understudied and may face a higher risk of serious heart-related events, including sudden cardiac death. Despite assumptions that collegiate athletes are uniformly healthy, there is a need to better understand hidden health risks in this population. Our research aims to improve how we identify and monitor early signs of cardiometabolic disease by examining markers such as inflammation, blood sugar, and cholesterol levels. These insights will help healthcare providers, athletes, and families make more informed decisions about nutrition, training, and long-term health. Ultimately, this work seeks to develop practical, evidence-based strategies to protect athlete health and reduce the risk of serious cardiovascular outcomes.

Automatically Transmitted Home Blood Pressure and Automated Patient Feedback in Hypertension Care: the AUTO 2 Trial

The purpose of this study is to evaluate the effectiveness of automatically-generated medical advice to patients about to their home blood pressure monitoring results sent through patient portal messages compared to no automated advice and the effectiveness of automated transmission of remotely-obtained blood pressure values compared to self-reported values on systolic blood pressure at 1-year follow up in patients with uncontrolled hypertension whose physicians or advance practice providers provide primary care at Northwestern Medicine. Persistence of effects through 18 months will also be assessed.

Cohort Study of Metabolic Disease and Hypertension

The goal of this observational study is to learn how type 2 diabetes and high blood pressure develop over time in adults in Mexico. The study will include men and women between 18 and 65 years of age who do not have a previous diagnosis of these conditions. The main questions this study aims to answer are: What factors increase the risk of developing type 2 diabetes? What factors increase the risk of developing high blood pressure? Participants will not receive any experimental treatment. Researchers will observe their health as part of their regular medical care. Participants will: Attend an initial visit that includes physical measurements, blood tests, and questionnaires about their health, lifestyle, and environment Perform a simple walking test to measure physical fitness Return once a year for follow-up visits over a period of five years During the study, researchers will monitor participants to identify new cases of type 2 diabetes and high blood pressure. The results of this study may help improve prevention strategies and support public health programs aimed at reducing chronic diseases in Mexico.

Community Health Worker Coaching to Reduce Cardiovascular Risk Among Women After a Hypertensive Disorder of Pregnancy

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone for women who had high blood pressure during pregnancy. The enhanced program combines RBPM with a lifestyle program led by a community health worker (CHW). The study will examine whether the enhanced program helps women better control their blood pressure, lowers their average resting blood pressure, improves heart health risk factors (such as weight, diet, physical activity), supports mental well-being, and reduces emergency department visits and hospital readmissions by 6 months after delivery.

The Effects of Brief Periods of Exercise on Blood Pressure

High blood pressure is a common medical condition that affects the body's arteries. It's also called hypertension. Untreated hypertension increases the risk of heart attack, stroke and other serious health problems. Exercise is a promising tool in hypertension management. Regular participation in exercise improves vascular health, heart and lung function, and multisystem health. However, the direct evidence of the treatment effects of a brief period of exercise on blood pressure in individuals with hypertension is limited. A brief period of exercise refers to an exercise protocol that only lasts for a very short period of time, such as 5-10 minutes.

Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension

The goal of this clinical trial is to study whether having a clinical decision support (CDS) tool available to clinician use will more effectively lower BP 4 weeks after an outpatient visit compared with usual care. The main objective is to assess the impact of the CDS tool, that is embedded with the electronic medical record (EMR), that is available during outpatient clinical encounters, on blood pressure (BP) changes among participants with uncontrolled hypertension. Participants will: Visit the clinic 4 weeks, after their initial clinician visit, for a BP check.

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.

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.

Integrating Care for Hypertension-Diabetes MULTImorbidity in Guatemala Through HEARTS Implementation

The purpose of this study is to find out whether a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care clinics deliver better treatment. It includes training for health workers, simpler treatment guides, better access to medicines, teamwork among clinic staff, and tracking systems to monitor patient care. In this study, 36 public primary care clinics in Guatemala will be randomly assigned to either use the HEARTS program or continue with their current care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study and again after 12 months. The main measures are blood pressure and hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months).

A Phase I Clinical Study of ART101 Injection in Healthy Adult Subjects

This is a Phase I clinical study, which is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation study. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single subcutaneous injection of ART101 injection in healthy adult subjects. This study is planned to include 5 dose groups, with an estimated maximum sample size of approximately 40 subjects. To reduce the safety risk to subjects, a sentinel method will be used in Dose Group 1, where 2 subjects (1 receiving the investigational drug and 1 receiving placebo) will be enrolled first, followed by 6 subjects (5 receiving the investigational drug and 1 receiving placebo). There will be at least a 7-day interval between the administration to the sentinel subjects and the other subjects in Dose Group 1. Subjects in each dose group will receive a single subcutaneous injection of ART101 injection or placebo on Day 1 after at least 8 hours of fasting. Group 1 Single subcutaneous injection 25 mg (N=6) Placebo (N=2) Group 2 Single subcutaneous injection 75 mg (N=6) Placebo (N=2) Group 3 Single subcutaneous injection 150 mg (N=6) Placebo (N=2) Group 4 Single subcutaneous injection 300 mg (N=6) Placebo (N=2) Group 5 (Optional) Single subcutaneous injection ≤600 mg (N=6) Placebo (N=2) The study procedures include a screening period, a treatment period, a follow-up period, and an early termination/study completion follow-up.

To Study the 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.

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

Empirical Study on Lifestyle Intervention for Elderly Hypertensive Patients in Community Based on TTM Theory

This study intervention is based on TTM theory and implements lifestyle interventions, including nutritious diet, regular exercise, social support, sleep optimization, avoidance of addictive substances, and stress management. Through various means such as training, guidance, and motivation, motivation is formed, goals are determined, and habits are strengthened, ultimately leading to the development of a healthy lifestyle, control of blood pressure indicators, and improvement of quality of life and cognitive function. The intervention period is a total of 3 weeks, on line.

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

This prospective single-center observational study aims to evaluate the relationship between elevated plasma homocysteine levels and early echocardiographic abnormalities in patients with newly diagnosed essential hypertension. Adult patients diagnosed with essential hypertension within the previous 6 months will undergo clinical assessment, ambulatory blood pressure monitoring, electrocardiography, laboratory testing, and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis when image quality is adequate. Participants will be classified according to plasma homocysteine level using, and patients with elevated and normal homocysteine levels will be compared with respect to diastolic dysfunction and left ventricular and left atrial global longitudinal strain parameters. Clinical, laboratory, and echocardiographic data will also be used to develop a machine-learning based model for prediction of H-type hypertension.

REmote Physical ACtivity Intervention for High Blood Pressure Postpartum

The purpose of this intervention is to help new mothers who had elevated blood pressure during pregnancy become more physically active after birth. The investigators will connect data from FitBits to the electronic health record. Women will then get weekly messages with feedback and goals to help them stay active. The investigators will test if the intervention improves step counts and blood pressure after pregnancy. The investigators will also test if the intervention is feasible and enjoyed by postpartum women.

NR and Exercise for Blood Pressure

Hypertension continues to pose a significant global health challenge, with rates of optimal blood pressure control remaining low - particularly in China, where fewer than 5% of individuals with hypertension achieve guideline-recommended targets. Age-associated endothelial dysfunction and arterial stiffness are recognized as the key contributors to the development of hypertension and the unique role of nicotinamide adenine dinucleotide (NAD) depletion in the pathogenesis of vascular dysfunction has been recently discovered. Treatment with nicotinamide riboside (NR), an NAD precursor, has shown promise in preliminary clinical trials for improving blood pressure and vascular health in at-risk populations. In parallel, aerobic exercise is a well-established non-pharmacologic intervention known to improve cardiovascular outcomes. Emerging studies suggest that exercise may modulate NAD biosynthesis pathways, pointing toward a synergistic potential when combined with NAD-boosting strategies. However, clinical data evaluating the combined effects of NR supplementation and aerobic exercise remain scarce. Our randomized, placebo-controlled, four-arm, parallel-group design seeks to address this gap. The investigators will investigate the independent and combined effects of 10-week NR supplementation and brisk walking on blood pressure and vascular health in post-menopausal women with elevated/stage I hypertension. This population is specifically targeted due to their heightened risk for vascular dysfunction post-menopause and the observed responsiveness to NR-based interventions in prior studies. The investigators believe the findings from this trial will provide insight into the feasibility, safety, and efficacy of combining NAD-boosting supplementation with structured exercise in a uniquely vulnerable and previously understudied population. The potential to identify a low-risk, non-pharmaceutical therapeutic approach holds strong implications for public health, particularly in aging women with early-stage hypertension.

Genetic Architecture of Natriuretic Peptides and Blood Pressure Response

Natriuretic peptides (NPs) are hormones produced by the heart and play an important role in maintaining cardiovascular health and have favorable metabolic benefits. Low NP levels are associated with an increased likelihood of the development of cardiometabolic diseases like diabetes and hypertension. NP levels are known to be highly heritable, with up to half of the differences in NP levels being explained by genetics. The investigators aim to describe the genetic architecture of NPs by examining the genetic variants associated with NPs, and generate and validate a polygenic score (PGS) for NPs. The investigators will use this NP PGS to examine the association of genetically determined NP levels with cardiometabolic and cardiovascular outcomes. The investigators will conduct a genotype-guided physiological clinical trial that aims to assess the genetic factors affecting NP levels and their impact on blood pressure and NP response to saline infusion, high-salt diet, and low-salt diet. These findings will help support personal medicine approaches to lower the increasing burden of hypertension in the United States.

Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal

Hypertension (HTN) and diabetes mellitus are significant global public health challenges, contributing to 13.5% of premature deaths, 54% of incident strokes, and 47% of coronary heart disease cases (HTN), and increasing risks of cardiovascular diseases, kidney failure, and other complications (diabetes). In Nepal, HTN prevalence is 24.5% and diabetes affects 5.8% of adults (2019 Nepal STEPS Survey), with many cases undiagnosed or poorly managed, and an estimated 60% co-morbidity among diabetic individuals. Nepal's Package of Essential Non-Communicable Diseases (PEN), implemented since 2017, targets both conditions, but multi-level barriers limit its facility-based effectiveness. This study addresses the need for cost-effective, evidence-based strategies for HTN and diabetes management in low-resource settings, focusing on marginalized populations. It proposes a Type II hybrid implementation-effectiveness study with two objectives: (1) evaluate implementation outcomes (reach, adoption, implementation, maintenance) of the Female Community Health Volunteers (FCHVs)-led integrated HTN and diabetes management using the RE-AIM framework; (2) assess effectiveness compared to facility-based PEN on systolic blood pressure and fasting blood sugar at 12 months. FCHVs will deliver integrated health education, form peer groups, and coordinate care. Using a mixed-method approach, the study involves a cluster randomized controlled trial with participants, collecting quantitative data on implementation, supplemented by in-depth interviews (8-16 patients) and focus group discussions (2 FGDs with FCHVs), with qualitative tracking logs. The intervention adapts a prior FCHV-led HTN trial to integrate diabetes management. FCHVs will receive 3-day training on screening, counseling, BP and blood sugar monitoring, and referrals for both conditions. Mass screening will identify HTN and diabetes cases, forming monthly FCHV groups for lifestyle counseling, BP, and glucose tracking, with family involvement. Monthly referrals will link uncontrolled cases to facilities. This aims to enhance integrated HTN and diabetes management, fostering community engagement and healthcare coordination, with findings to inform scalable NCD strategies in Nepal.

A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease

A study Comparing the Clinical Benefit of Finerenone Versus a Fixed-Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients with Hypertension and Chronic Kidney Disease.