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 Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
NCT05924477 · Glaucoma
RecruitingGlaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.
PhaseNA
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 7 more
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Park-Based Programs for Health Promotion: Active Older Adults Prospective Cohort Study
NCT06604650 ·
Hypertension, Overweight, Obesity
RecruitingThe Active Older Adults prospective cohort study examines the effects of a park-based fitness program on cardiovascular fitness outcomes for older adults (aged 50 years and older). Duke will perform a secondary analysis of the data collected as part of the Active Older Adults prospective cohort study run by Miami-Dade County Parks and Recreation.
Phase—
TypeObservational
Age50 Years – 95 Years
WhereMiami, Florida, United States
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY3971297 in Healthy Participants
NCT06148272 · Healthy, Obesity,
Hypertension RecruitingThe purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
PhasePhase 1
TypeInterventional
Age18 Years – 75 Years
WhereAnaheim, California, United States + 6 more
SponsorEli Lilly and Company
▾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 + 6 more
SponsorNovartis Pharmaceuticals
▾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 Biomarkers of Ocular Surface Damage in the Setting of Topical Ocular Hypotensive Medication Use
NCT07217678 · Glaucoma, Open-Angle Glaucoma,
Ocular Hypertension RecruitingThe objective of this study is to evaluate whether reduction in topical medication with the injection of a sustained release capsule (Durysta) leads to a reduction in ocular surface inflammation, indicated by levels of caspase-1, an inflammatory biomarker.
PhasePhase 4
TypeInterventional
Age18 Years
WhereMiami, Florida, United States
SponsorUniversity of Miami
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Park-Based Programs for Health Promotion: The Fit2Lead Prospective Cohort Study
NCT06596265 ·
Anxiety, Wellness, Psychological, Overweight or Obesity
RecruitingThe Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.
Phase—
TypeObservational
Age12 Years – 17 Years
WhereMiami, Florida, United States
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)
NCT03138863 · Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia,
Pulmonary Artery Hypertension RecruitingThe purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).
PhaseNA
TypeInterventional
Age18 Years – 50 Years
WhereMiami, Florida, United States + 1 more
SponsorRodrigo Ruano
▾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 + 128 more
SponsorOrchestra BioMed, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Global Paradise System US Post Approval Study
NCT06297291 ·
Hypertension, Cardiovascular Diseases, Vascular Diseases
RecruitingThe objective of the Global Paradise® System US Post Approval Study (US GPS) is to evaluate the real-world use of the Paradise Ultrasound Renal Denervation System indicated for patients who are unable to lower their blood pressure with lifestyle changes and medication. This system is comprised of a catheter, cable, balloon, and generator and has received FDA approval in the United States. Information collected in this study will be analyzed to better understand the long-term safety and effectiveness of treatment with the Paradise System for patients with high blood pressure.
Phase—
TypeObservational
Age18 Years
WhereSacramento, California, United States + 38 more
SponsorReCor Medical, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Non-Invasive Preeclampsia Screening and Biobank
NCT06643741 · Preeclampsia (PE)
RecruitingWomen pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Phase—
TypeObservational
Age18 Years
WhereGlendale, Arizona, United States + 20 more
SponsorSequenom, 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 + 4 more
SponsorZona Health, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Community Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study
NCT06595251 · Overweight, Obesity,
Hypertension RecruitingThe Fit2Play prospective cohort study examines the effects of a park-based youth physical activity afterschool program on youth participant fitness and mental health outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Play prospective cohort study run by Miami-Dade County Parks and Recreation.
Phase—
TypeObservational
Age6 Years – 14 Years
WhereMiami, Florida, United States
SponsorDuke University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
RecruitingThis 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.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 9 more
SponsorBiobeat Technologies Ltd.
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