Community-based Approach to Lowering Stress Through Mindfulness
RecruitingThe goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are: * Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms? * Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control? * Is the intervention acceptable, appropriate, and feasible as delivered in a community setting? Participants will: * Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation. * Complete surveys online * Have their blood pressure measured with a non-invasive blood pressure cuff * Attend 1 focus group (optional)
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT07064473 · Diabetes Mellitus, Type 2,
Hypertension, Cardiovascular Diseases
RecruitingThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnniston, Alabama, United States + 1151 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts MegaNatural BP® GSE on Blood Pressure and Cardiometabolic Risk Factors
NCT06555952 ·
Hypertension, Pre Diabetes
RecruitingInflammation and stressors can interfere with the function of the lining of blood vessels and insulin activity, therefore, investigators are aiming to see how the Grape seed Extract (GSE) called MegaNatural BP can help with limiting the effects of these factors. This research will study the effects of taking 150mg of MegaNatural BP GSE per day on blood pressure levels along with influences on heart health through assessing the function of the blood vessel lining and levels of inflammation.
PhaseNA
TypeInterventional
Age40 Years – 60 Years
WhereChicago, Illinois, United States
SponsorClinical Nutrition Research Center, Illinois Institute of Technology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Intervention to Reduce CardiovascuLar Disease in Chicago
NCT04755153 ·
Hypertension RecruitingHypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides. Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities. Therefore, the overall goal is to support a community-centered design and adaptation of the Kaiser bundle. The investigative team will adapt the delivery model of the Kaiser bundle to be centered within churches within the South Side of Chicago, one of the most medically underserved communities in the United States. The proposed interventions are the same as in the Kaiser bundle (e.g., registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement) but implementation of the components of the bundle will be adapted for delivery in the community. The intervention will be carried out by local community health workers and ministry facilitators, with health clinics and hospitals in the community as support, all connected through a common data platform. Thus, the proposed project will identify the best strategies to support adoption, implementation with fidelity, and sustainability of the Kaiser bundle in the community setting. The proposed study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) evaluation framework. The specific aims are: Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model. Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within the target community. Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. The study uses a hybrid Type 3 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcomes reach (implementation) and blood pressure (clinical effectiveness). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.
PhaseNA
TypeInterventional
Age18 Years – 89 Years
WhereChicago, Illinois, United States + 2 more
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
NCT04278404 · Coronavirus Infection (COVID-19),
Pulmonary Arterial Hypertension, Urinary Tract Infections in Children
RecruitingThe study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
Phase—
TypeObservational
Age0 Years – 20 Years
WherePhoenix, Arizona, United States + 50 more
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
NCT07181109 · High Risk Cardiovascular Disease,
Hypertension, High Cardiovascular Risk
RecruitingThe purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 741 more
SponsorAlnylam Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mobile Health Interventions to Prevent Heart Disease After Hypertensive Disorders of Pregnancy
NCT06523569 ·
Hypertension in Pregnancy, Pre-Eclampsia, Eclampsia
RecruitingThe purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).
PhaseNA
TypeInterventional
Age18 Years – 99 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clarifying the Optimal Application of SLT Therapy Trial
RecruitingThe goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLaguna Hills, California, United States + 28 more
SponsorUniversity of Pittsburgh
▾Tap for detailsClick for full details — eligibility, all locations, contacts Aspirin and Preeclampsia
NCT04479072 · Preeclampsia Postpartum
RecruitingThis is a single-center, double-blind, randomized, placebo-controlled clinical trial. Peripartum and postpartum Activin A are significantly elevated in women with preeclampsia. Our hypothesis is that elevated Activin A levels reflect a remediable signal and that reducing postpartum Activin A levels with aspirin therapy will improve (GLS) in preeclamptic patients.
PhasePhase 4
TypeInterventional
Age18 Years – 45 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingThis is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 61 more
SponsorUnited Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary Hypertension
NCT06911632 ·
Pulmonary Hypertension, Interstitial Lung Disease (ILD)
RecruitingMOMENTOUS is a multi-center, randomized study to prospectively evaluate the performance of an ECG-based AI device to predict whether participants with interstitial lung disease (ILD) are at high risk of undiagnosed pulmonary hypertension.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 24 more
SponsorTempus AI
▾Tap for detailsClick for full details — eligibility, all locations, contacts To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension
RecruitingThis is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereLittle Rock, Arkansas, United States + 28 more
SponsorE-Star BioTech, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
NCT03487185 · Obstructive Sleep Apnea of Adult, Preeclampsia, Obstetrical Complications
RecruitingA randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 13 more
SponsorThe George Washington University Biostatistics Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Church-based Intervention to Improve Blood Pressure in African Americans
NCT05220332 ·
Hypertension RecruitingThis is a 12-month behavioral cluster-randomized trial testing a church-based intervention to reduce blood pressure in African Americans with uncontrolled blood pressure.
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorRush University Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
RecruitingA prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
PhaseNA
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 128 more
SponsorOrchestra BioMed, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Perimetric Testing With Virtual Reality
NCT06549010 · Glaucoma
RecruitingPerimetry is an essential component in the diagnosis and monitoring of glaucoma. Since the advent of Standard Automated Perimetry (SAP), one of the clinical standards has been the Humphrey Field Analyzer (HFA, Carl Zeiss AG, Oberkochen, Germany). Visual field (VF) testing provided by the HFA is standard-of-care in glaucoma clinics and other ophthalmology and optometry practices. However, the HFA is a large device that does not allow for examination outside the clinic and can be uncomfortable for patients with limited mobility. This study aims to evaluate a novel head-mounted perimeter against the HFA as an alternative method of VF testing. This new perimeter uses a Virtual Reality (VR) headset and a gamified version of VF testing to assess the visual function of healthy eyes and patients. The results of this study will potentially serve as pilot data for the design of a larger study that involves the full assessment of the VR headset and its VF test, based on various testing strategies.
PhaseNA
TypeInterventional
Age25 Years – 70 Years
WhereChicago, Illinois, United States
SponsorEnvision Health Technologies, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of the Progression of Chronic Cardiovascular Conditions
NCT07420907 · Cardiovascular Disease (CVD),
Heart Failure, Aortic Stenosis
RecruitingThis study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.
Phase—
TypeObservational
Age18 Years
WhereChicago, Illinois, United States
SponsorProlaio
▾Tap for detailsClick for full details — eligibility, all locations, contacts Interactive Computer-adaptive Chronic Kidney Disease Education Program
NCT06364358 · Chronic Kidney Diseases,
Hypertension RecruitingThe goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC
PhaseNA
TypeInterventional
Age18 Years – 70 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
RecruitingThe long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States + 1 more
SponsorMedical College of Wisconsin
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
NCT06843577 · Elevated Blood Pressure,
Hypertension RecruitingThe study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
PhaseNA
TypeInterventional
Age22 Years
WhereValley Village, California, United States + 4 more
SponsorZona Health, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts