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 + 36 more
SponsorTempus AI
▾Tap for detailsClick for full details — eligibility, all locations, contacts Preparing FIM-BCS - A Lifestyle Modification for African-American Breast Cancer Survivors
NCT06504914 ·
Hypertension, Obesity, Nutrition, Healthy
RecruitingHypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention \- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
PhaseNA
TypeInterventional
Age18 Years – 99 Years
WhereChicago, Illinois, United States
SponsorUniversity of Illinois at Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts Preventative Screening and Health Coaching in a Food Insecure Population
NCT06907524 · Cardiovascular Disease Prevention, Cardiometabolic Diseases, Cardiovascular Risk Factor
RecruitingThe goal of this longitudinal study is to investigate the role of virtual health coaching on mitigation of cardiometabolic disease risk in an underserved, food insecure population. The main questions it aims to answer are: * Does longitudinal, individualized health coaching directed at lifestyle modification reduce patient 10-year risk of heart attack or stroke? * Does longitudinal, individualized health coaching directed at lifestyle modification reduce rates of hypertension, hyperlipidemia, and diabetes? * Does longitudinal, individualized health coaching directed at lifestyle modification improve accessibility to healthcare? Researchers will investigate the effects of regularly scheduled health coaching sessions on composite cardiometabolic risk profile as well as individual modifiable cardiovascular risk factors. Participants will: * Participate in in-person cardiovascular screening, occuring at the time of enrollment, months 3 and 6. * Engage in virtual health coaching sessions to talk about diet, exercise, weight loss, blood pressure and diabetes control, and accessibility to healthcare * Keep a log of their blood pressure
PhaseNA
TypeInterventional
Age40 Years – 75 Years
WhereChicago, Illinois, United States
SponsorRush University Medical Center
▾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 + 70 more
SponsorUnited Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
RecruitingThe purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WhereAlexander City, Alabama, United States + 140 more
SponsorTenax Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 Intensive Patient Referral and Education Program Prior to Renal Replacement Therapy
NCT06397456 · Chronic Kidney Disease,
Hypertension RecruitingIntensive Patient Referral and Education Program prior to Renal Replacement Therapy (iPREP-RRT) is a 12-week intervention that identifies hospitalized African Americans with advanced chronic kidney disease (CKD) and provides them with hospital- and community-based education, navigation and self-management support. Participants will be randomized to the iPREP-RRT intervention versus enhanced usual care.
PhaseNA
TypeInterventional
Age18 Years – 70 Years
WhereChicago, Illinois, United States
SponsorUniversity of Chicago
▾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 + 1146 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
NCT06526195 ·
Heart Failure, Heart Diseases, Cardiovascular Diseases
RecruitingThe purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.
PhaseNA
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 67 more
SponsorAbbott Medical Devices
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Pharmacodynamics of a Combination of QCZ484 and Inclisiran in Participants With Hypertension and Concomitant Hypercholesterolemia
NCT07610278 · Hypercholesterolaemia
RecruitingThis is a multicenter, randomized, double-blind, factorial design Phase 2 study to evaluate the pharmacodynamics, safety and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484, inclisiran, and placebo in participants with hypertension and concomitant hypercholesterolemia.
PhasePhase 2
TypeInterventional
Age18 Years – 75 Years
WhereFoley, Alabama, United States + 28 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Mosliciguat in Combination With Inhaled Treprostinil in PH-ILD
NCT07333183 ·
Pulmonary Hypertension, Interstitial Lung Disease (ILD), Lung Diseases
RecruitingThis is a Phase 2, open-label, multi-center clinical study to evaluate the safety and tolerability of inhaled mosliciguat in participants with pulmonary hypertension associated with interstitial lung disease (PH-ILD) on a background inhaled treprostinil.
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereSanta Barbara, California, United States + 12 more
SponsorPulmovant, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
NCT07332741 ·
Hypertension,
Hypertension (HTN), Obesity & Overweight
RecruitingThe 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?
PhasePhase 2
TypeInterventional
AgeAny
WhereChicago, Illinois, United States + 3 more
SponsorUniversity of Illinois at 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 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 + 1104 more
SponsorAlnylam Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Predict Severe Traumatic Brain Injury
NCT06966713 · Traumatic Brain Injury
RecruitingSevere traumatic brain injury (TBI) is associated with a 20-30% mortality rate and significant disability among most survivors. The Centers for Disease Control and Prevention (CDC) estimate that 2% of the U.S. population lives with disabilities directly attributable to TBI, with annual costs exceeding $76.5 billion. Current treatments are largely ineffective because they are instituted after irreversible damage has already occurred. By the time intracranial pressure (ICP) increases or brain tissue oxygen tension (PbtO2) decreases to harmful levels, it is often too late to reverse or repair the damage. A computerized method has been developed that can predict these injurious events ahead of time, allowing clinicians to intervene before further damage occurs. The goal of this proposal is to test these predictions in real time. The first phase of the project (Year 1) involves setting up the informatics infrastructure, with no patient interaction. In the second phase (Year 2), subjects, through surrogate decision-makers, will be enrolled in an observational study where data on intracranial pressure and brain tissue oxygen tension will be collected, and the prediction algorithm will be tested for accuracy. Clinical management will follow standard care protocols, and no additional interventions will be performed. Approximately 120 individuals will participate in this study at the University of Chicago and Ben Taub General Hospital in Houston. Data collected will include both the electronic medical record and data from bedside intensive care unit monitors. The electronic medical record includes demographic information, injury characteristics, laboratory values, and imaging data, while the intensive care unit monitor provides real-time vital signs such as intracranial pressure, brain tissue oxygen tension, and mean arterial pressure. These data will be securely stored in a research computer database. Efforts will be made to contact subjects or their caretakers at 6 months to follow up on recovery. This research aims to improve patient outcomes by providing predictions of further brain injury, with the potential for future interventions to prevent permanent brain damage.
Phase—
TypeObservational
Age18 Years
WhereChicago, Illinois, United States + 1 more
SponsorUniversity of Chicago
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Open-label Extension Safety and Efficacy Study of QCZ484 in Hypertensive Patients.
RecruitingThe 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.
PhasePhase 2
TypeInterventional
Age18 Years
WhereGarden Grove, California, United States + 24 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts Mobilizing Community Hypertension Access Pilot
NCT07547345 ·
Hypertension RecruitingThe Live Healthy Chicago (LHC) Community Pilot is a prospective, community-based study evaluating the feasibility, effectiveness, and economic impact of a pharmacist-led hypertension management program delivered in trusted community settings on the West and South Sides of Chicago. Adults with uncontrolled hypertension will be identified and enrolled through community-based organizations, where a mobile clinical team-including community health workers, a pharmacist, and a registered nurse-will provide blood pressure screening, medication management, health education, and care coordination over a 3-month period. The study will assess participant engagement and acceptability, changes in systolic blood pressure. This pilot aims to address disparities in hypertension control by improving access to care in underserved communities and informing scalable, community-based models of chronic disease management.
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorRush University Medical Center
▾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 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 + 130 more
SponsorOrchestra BioMed, Inc
▾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 + 9 more
SponsorZona Health, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts