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 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 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 LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
RecruitingThis study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
PhasePhase 3
TypeInterventional
Age18 Years – 85 Years
WhereTucson, Arizona, United States + 43 more
SponsorTenax Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts E3 Hypertension - A Team-based, Multidisciplinary Model in Addressing Barriers to Hypertension Control
NCT06899750 ·
Hypertension RecruitingThis study aims to compare a multidisciplinary clinical hypertension and social needs intervention to enhanced standard of care for hypertension management in primary care clinics with regards to hypertension control outcomes.
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorRush University Medical Center
▾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 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 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 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 Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
NCT06039176 · LVAD, Frailty, GI Bleed
RecruitingDurable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.
Phase—
TypeObservational
Age18 Years – 100 Years
WhereSan Francisco, California, United States + 6 more
SponsorInternational Consortium of Circulatory Assist Clinicians
▾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 A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
RecruitingTX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
PhasePhase 2
TypeInterventional
Age18 Years – 83 Years
WherePhoenix, Arizona, United States + 85 more
SponsorTectonic Therapeutic
▾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 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 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 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients
RecruitingThe diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods. STUDY ENDPOINTS: Primary Outcome Measures: * Agreement between conical and cylindrical cuff systolic blood pressure across groups * Agreement between conical and cylindrical cuff diastolic blood pressure across groups Secondary Outcome Measures: • Agreement between conical and cylindrical cuff mean arterial pressure
PhaseNA
TypeInterventional
Age18 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
NCT06468202 · Hypertensive Disorders of Pregnancy, Preeclampsia,
Gestational Hypertension RecruitingThe overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.
PhasePhase 4
TypeInterventional
Age14 Years – 35 Years
WhereBirmingham, Alabama, United States + 15 more
SponsorOhio State University
▾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 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 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