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 A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
RecruitingResearchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 114 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)
RecruitingA study to learn about the treatment LTP001 in healthy participants (Part A) and in participants with PAH (Part B)
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 100 Years
WhereScottsdale, Arizona, United States + 84 more
SponsorNovartis Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
RecruitingInternational, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
PhasePhase 3
TypeInterventional
Age18 Years
WhereFairhope, Alabama, United States + 760 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
NCT04163614 · End Stage Renal Disease,
Hypertension, Extracellular Volume Overload
RecruitingKidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.
PhaseNA
TypeInterventional
Age18 Years
WhereDallas, Texas, United States
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts SPYRAL GEMINI Pilot Study
NCT06907147 ·
Hypertension, Vascular Diseases, Cardiovascular Diseases
RecruitingThe purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.
PhaseNA
TypeInterventional
Age18 Years – 80 Years
WhereStanford, California, United States + 15 more
SponsorMedtronic Vascular
▾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 IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
NCT06218355 · Postpartum Complication
RecruitingThe purpose of this study is to compare two complex, multi-component evidence-based postpartum interventions in underserved populations of lower socioeconomic status in an effort to reduce maternal morbidity and mortality.
PhaseNA
TypeInterventional
Age18 Years
WhereAtlanta, Georgia, United States + 1 more
SponsorUniversity of Texas Southwestern Medical Center
▾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 Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
NCT06313749 · Primary Open Angle Glaucoma, Open Angle Glaucoma
RecruitingThe goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy. Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
PhaseNA
TypeInterventional
Age40 Years – 85 Years
WhereDallas, Texas, United States
SponsorSanoculis Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health \& Hospital System.
PhaseNA
TypeInterventional
Age70 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pulmonary Hypertension Association Registry
RecruitingThe PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care.
Phase—
TypeObservational
Age0 Years
WherePhoenix, Arizona, United States + 51 more
SponsorPulmonary Hypertension Association, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Assessing the Efficacy of Targeted Home Visits in the Management of Chronic Conditions
RecruitingThe purpose of study is to evaluate whether home visit programs are an effective method for HTN and T2DM management as compared to standard of care clinic visits.
PhaseNA
TypeInterventional
Age18 Years – 60 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
NCT07220876 · Open Angle Glaucoma (OAG)
RecruitingA Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
PhaseNA
TypeInterventional
Age45 Years
WhereGlendale, Arizona, United States + 11 more
SponsorAvisi Technologies Inc.
▾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 Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
NCT03471117 · Chronic Kidney Diseases
RecruitingChronic kidney disease (CKD) is associated with a higher risk of cardiovascular disease and death. An overactive sympathetic nervous system in CKD patients is one of the major mechanisms increasing the cardiovascular risks in this patient population. Recently, some studies have shown that a drug typically used to improve glucose control (pioglitazone) may also reduce sympathetic nerve activity and improve blood vessel function. The goal of this study is to determine whether a short-term treatment with pioglitazone can reduce sympathetic nerve impulses throughout the body in CKD patients.
PhasePhase 4
TypeInterventional
Age35 Years – 70 Years
WhereArlington, Texas, United States + 1 more
SponsorThe University of Texas at Arlington
▾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 A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma
NCT06822738 · Primary Open Angle Glaucoma
RecruitingGlaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
PhasePhase 3
TypeInterventional
Age45 Years
WhereGlendale, Arizona, United States + 23 more
SponsorAbbVie
▾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