External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial
NCT05889650 · Severe Traumatic Brain Injury,
Intracranial Hypertension RecruitingThe goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \<5mm without increasing the risk of neurological worsening or cerebral herniation. All participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereGainesville, Florida, United States + 5 more
SponsorBrain Trauma Foundation
▾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 + 26 more
SponsorAbbVie
▾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 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
WhereLong Beach, California, United States + 42 more
SponsorReCor Medical, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
RecruitingThis open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereFresno, California, United States + 119 more
SponsorGossamer Bio USA, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
RecruitingThe goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001
PhasePhase 2
TypeInterventional
Age18 Years – 70 Years
WhereAlexander City, Alabama, United States + 23 more
SponsorRetension Pharmaceuticals. Inc.
▾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 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 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 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 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 + 17 more
SponsorMedtronic Vascular
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)
NCT04838678 ·
Hypertension, Obesity
RecruitingThe purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction.
PhaseEARLY_Phase 1
TypeInterventional
Age18 Years – 55 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾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 + 770 more
SponsorAstraZeneca
▾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 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 Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
NCT06402968 · Intracerebral Hemorrhage, Stroke,
Hypertension RecruitingThe aim is to compare the rate of hypertensive subjects with ICH who reach SBP target with stability within 60 minutes of enrollment, among patients treated with IV clevidipine with those treated with alternate IV antihypertensive regimen.
Phase—
TypeObservational
Age18 Years – 100 Years
WhereIrvine, California, United States + 19 more
SponsorZeenat Qureshi Stroke Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Hydrus® Microstent New Enrollment Post-Approval Study
NCT04553523 · Primary Open Angle Glaucoma
RecruitingThe purpose of this post-approval study is to evaluate the rate of Hydrus Microstent malposition and associated clinical sequelae occurring within 24 months post-operation. Qualified subjects will undergo uncomplicated cataract surgery with placement of a monofocal intraocular lens (IOL), followed by implantation of the Hydrus Microstent.
PhaseNA
TypeInterventional
Age45 Years
WhereIrvine, California, United States + 21 more
SponsorAlcon Research
▾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 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