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 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 A Phase 3 Study to Evaluate the Safety and Efficacy L606 in Participants With PH-ILD
RecruitingThe purpose of this study is to find out if L606 is safe and if it helps people with high blood pressure in the lungs (pulmonary hypertension) caused by interstitial lung disease (PH-ILD, WHO Group 3). One of the main ways the study will check this is by seeing if people can walk further in six minutes (called the "six-minute walk test"). Another important (secondary) goal is to see how long it takes for PH-ILD to get worse while people are taking L606. One way the study will measure this is by looking at the distance people walk at different times in the study on different doses of L606. Throughout the study, doctors will also closely monitor for any side effects people have to make sure L606 is safe. People who decide to join this study will be randomly (like tossing a coin) placed into one of two groups: one group will get L606 and the other group will get a placebo, which will look like L606 but will not contain any active medicine. At the end of the initial blinded portion of the study, study participants may have the opportunity to enroll in an open-label extension portion of the study where all participants will receive L606.
PhasePhase 3
TypeInterventional
Age18 Years – 80 Years
WhereScottsdale, Arizona, United States + 15 more
SponsorLiquidia Technologies, Inc.
▾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 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 + 66 more
SponsorUnited Therapeutics
▾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 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 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 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 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 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 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 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 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 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 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 + 25 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts The REACH-OUT Trial
NCT07540143 ·
Hypertension, Reproductive Behavior, Primary Health Care
RecruitingTest the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.
PhaseNA
TypeInterventional
Age18 Years – 44 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾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 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 + 994 more
SponsorAlnylam Pharmaceuticals
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