[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypertension":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,508,0,25,[9,48,82,116,136,159,190,217,244,268,294,312,345,365,388,413,437,459,481,502,527,549,570,598,621],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054231","phase-4-spiro-first-a-pragmatic-primary-care-embedded-pilot-trial-of-renin-guided-first-line-antihypertensive-therapy-100054231",false,"NCT07687160","SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy","SPIRO-First","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Under the care of a primary care clinician in Ontario.\n3. Standardized office systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg.\n4. Mean daytime baseline ABPM systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg.\n5. Treating primary care clinician has independently determined that initiation of antihypertensive pharmacotherapy is clinically indicated.\n6. Either:\n\n   * Not currently receiving antihypertensive therapy, OR\n   * Receiving a single antihypertensive medication (ACE inhibitor, ARB, thiazide\u002Fthiazide-like diuretic, or calcium channel blocker) which the treating primary care clinician considers safe to discontinue for a 2-week washout period.\n7. Suppressed renin defined as direct renin concentration \\\u003C6 ng\u002FL (\\\u003C10 mU\u002FL) measured under routine outpatient conditions. Suppressed renin was selected as the primary biologic enrichment criterion because it is the physiologic hallmark of sodium-retaining, aldosterone-mediated hypertension and is more pragmatically scalable in primary care than complex biochemical primary aldosteronism (PA) definitions.\n8. In the opinion of the treating primary care clinician, outpatient participation in the study is appropriate.\n\nExclusion Criteria:\n\n1. Standardized office systolic blood pressure \\>170 mmHg if untreated OR \\>150 mmHg if receiving one antihypertensive medication.\n2. Known diagnosis of PA requiring specialist-directed management.\n3. Known secondary hypertension requiring disease-specific therapy.\n4. Current use of MR antagonists.\n5. Known intolerance or contraindication to spironolactone, candesartan, hydrochlorothiazide, or amlodipine.\n6. eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n7. Serum potassium ≥5.0 mmol\u002FL.\n8. Serum sodium \\\u003C135 mmol\u002FL.\n9. Pregnancy, breastfeeding, or intention to become pregnant during the study period. Women of childbearing potential must have a negative pregnancy test prior to randomization.\n10. Participation in another interventional study likely to affect blood pressure.\n11. Inability to provide consent","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to determine whether a renin-guided antihypertensive treatment strategy is feasible to implement in community primary care clinics and to explore whether spironolactone improves blood pressure control in adults with low-renin hypertension.\n\nThe main questions it aims to answer are:\n\nIs it feasible to identify, recruit, randomize, and follow adults with low-renin hypertension in a pragmatic primary care-based clinical trial?\n\nDoes first-line treatment with spironolactone result in greater reductions in ambulatory blood pressure compared with standard first-line antihypertensive therapy among adults with low-renin hypertension?\n\nResearchers will compare spironolactone 25 mg daily with standard first-line antihypertensive therapy (candesartan, hydrochlorothiazide, or amlodipine) to determine whether spironolactone provides better blood pressure control in adults with low-renin hypertension.\n\nParticipants will:\n\nUndergo blood pressure assessments, blood tests, and ambulatory blood pressure monitoring (ABPM) to determine eligibility.\n\nBe randomly assigned to receive either spironolactone or a standard first-line antihypertensive medication for 12 weeks.\n\nComplete follow-up visits and laboratory testing to monitor blood pressure response, kidney function, electrolyte levels, medication adherence, and side effects.\n\nUndergo repeat blood pressure measurements and ABPM at the end of the study.",[27],"Hypertension",[29,30,31,32,33,34],"hypertension","Renin-Guided Therapy","Antihypertensive treatment","Spironolactone","Precision Medicine","Primary aldosteronism","NOT_YET_RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":21},"2026-09-01",{"date":43,"type":21},"2028-02",{"name":45,"class":46},"Ottawa Hospital Research Institute","OTHER",3,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":57,"type":21},11000,[59],"PHASE3","The 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.",[62,27,63],"High Risk Cardiovascular Disease","High Cardiovascular Risk",[65,66,67,68,69,70,71],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi","RECRUITING",{"date":38,"type":39},{"date":75,"type":39},"2025-09-22",{"date":77,"type":21},"2030-09-30",{"name":79,"class":80},"Alnylam Pharmaceuticals","INDUSTRY",995,{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":89,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":102,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100053713","facilitated-transitions-from-postpartum-to-primary-care-coordination-for-people-with-chronic-conditions-100053713","NCT06557005","Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions","Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions","Inclusion Criteria\n\n* Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* Has one or more of the following conditions listed in the \"Problem List,\" \"Medical History,\" or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):\n\n  * Chronic or essential hypertension\n  * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n  * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n  * Gestational diabetes\n  * Class II Obesity (pre-pregnancy body mass index ≥35 kg\u002Fm2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg\u002Fm2)\n  * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient's medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read\u002Fspeak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria","FEMALE",{"count":91,"type":21},1320,[93],"NA","The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the \\>30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.",[27,96,97,98,99,100,101],"Diabetes","Postpartum","Pregnancy","Anxiety","Depression","Obesity",[103,104,105,106],"Postpartum Care","Primary Care","Care Transitions","Chronic Disease","2026-07-09",{"date":38,"type":39},{"date":110,"type":39},"2025-05-23",{"date":112,"type":21},"2028-05-23",{"name":114,"class":46},"Massachusetts General Hospital",1,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":22,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":115},"100054290","reach-out-2-emergency-department-initiated-hypertension-mobile-health-intervention-connecting-multiple-health-systems-100054290","NCT06391073","Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems","Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems","While in the ED, the patient must meet all of the following:\n\n* Adult (≥18 y\u002Fo)\n* At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100 (criteria 1)\n* If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains systolic BP ≥140 or a diastolic BP ≥90\n* Must have cell phones with text-messaging capability\n* Likely to be discharged from the ED\n\nExclusion Criteria for Main Trial Participants:\n\n* Critical illness\n* Unable to read English (\\\u003C1% at study site)\n* Incarcerated\n* Pregnant\n* Pre-existing condition making 6-month follow-up unlikely","99 Years",{"count":125,"type":21},500,[93],"Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.",[27],{"date":38,"type":39},{"date":131,"type":39},"2024-07-22",{"date":133,"type":21},"2028-11-30",{"name":135,"class":46},"Northwestern University",{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":115},"100053844","virtual-lifestyle-medicine-group-visits-for-high-blood-pressure-100053844","NCT07698509","Virtual Lifestyle Medicine Group Visits for High Blood Pressure","A Scalable, Lifestyle Medicine Intervention for Hypertension Using Virtual Group Shared Medical Appointments","Inclusion Criteria:\n\n* Current diagnosis of hypertension (ICD codes I10.0-I14.0 billed within the last 5 years Essential HTN, Essential HTN, Primary HTN)\n* Currently receives care at a UTPhysicians; Last seen by a PCP at Victory location within the last 1 year.\n* Able to participate in a virtual format\n* Willingness to participate and engage in home blood pressure monitoring\n\nExclusion Criteria:\n\n* Unstable cardiovascular disease (recent Myocardial Infarction (MI), unstable angina, decompensated HF)\n* Advanced Chronic kidney disease (CKD) (eGFR \\\u003C 30) without nephrology co-management\n* Active cancer treatment\n* Severe cognitive impairment (unable to engage)\n* Uncontrolled psychiatric illness (e.g., active psychosis)\n* Resistant hypertension (requiring\\> 3 medications at maximum doses)\n* Unable to participate in English class format\n* Unstable internet or lack of smartphone",{"count":144,"type":21},18,[93],"The purpose of this study is to learn whether virtual Lifestyle medicine shared medical appointments (LMSMAs) can help people better manage their blood pressure and improve their overall health.",[27],[149,150],"high blood pressure","Lifestyle medicine shared medical appointments (LMSMAs)","2026-07-06",{"date":38,"type":39},{"date":154,"type":21},"2026-08-03",{"date":156,"type":21},"2027-02-07",{"name":158,"class":46},"The University of Texas Health Science Center, Houston",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":115},"100638514","eit-evaluation-of-different-antihypertensive-agents-on-the-ventilation-perfusion-ratio-in-patients-with-acute-respiratory-failure-100638514","NCT07603037","EIT Evaluation of Different Antihypertensive Agents on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure","Effect of Nicardipine and Nitroglycerin on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure Using Electrical Impedance Tomography: A Prospective Pilot Study","Inclusion Criteria Diagnosis of acute respiratory failure with PaO₂\u002FFiO₂ ≤ 300 mmHg, requiring invasive mechanical ventilation.\n\nRequires intravenous antihypertensive infusion (such as nicardipine or nitroglycerin) to maintain controlled and stable blood pressure during ICU treatment.\n\nWritten informed consent obtained from the patient or the legally authorized representative.\n\nExclusion Criteria:\n\nBody mass index (BMI) ≥ 50 kg\u002Fm² or presence of massive subcutaneous edema interfering with EIT signal acquisition.\n\nImplanted cardiac pacemaker, defibrillator, or any metallic thoracic device that may distort impedance measurements.\n\nHemodynamic instability or severe hypotension occurring during drug titration. Pregnancy or lactation. Known hypersensitivity or contraindication to nicardipine or nitroglycerin. Use of phosphodiesterase-5 inhibitors, such as sildenafil, tadalafil, or vardenafil, within the clinically relevant washout period.\n\nSevere anemia, markedly increased intracranial pressure, or other clinical conditions in which nitroglycerin administration is considered inappropriate by the treating physician.\n\nIncomplete clinical documentation preventing accurate evaluation of primary endpoints.",{"count":167,"type":21},12,[93],"This prospective, single-center interventional study aims to evaluate the effect of two commonly used intravenous antihypertensive agents - nicardipine and nitroglycerin - on lung ventilation-perfusion (V\u002FQ) distribution in patients with acute respiratory failure complicated by hypertension. Electrical Impedance Tomography (EIT) will be used for noninvasive monitoring of pulmonary ventilation and perfusion distribution before and after drug administration.\n\nThe study will compare the changes in V\u002FQ ratio, oxygenation index, and hemodynamic variables after administration of the two drugs. The findings are expected to provide evidence for the optimal antihypertensive strategy in critically ill patients with respiratory failure and to clarify whether specific vasodilators exacerbate or improve ventilation-perfusion mismatch.",[171,27,172,173],"Acute Respiratory Failure (ARF)","Pulmonary Perfusion Imbalance","Aortic Dissection (Subset)",[175,176,177,178,179,180],"Electrical Impedance Tomography","Ventilation-Perfusion Ratio","Nicardipine","Acute Respiratory Failure","Intensive Care Unit","Nitroglycerin","2026-06-30",{"date":183,"type":39},"2026-07-02",{"date":185,"type":21},"2026-07-15",{"date":187,"type":21},"2027-07-30",{"name":189,"class":46},"First Affiliated Hospital of Wannan Medical College",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":216},"100632259","phase-2-study-of-efficacy-and-safety-of-tonlamarsen-in-participants-with-a-recent-hospitalization-and-a-concurrent-episode-of-acute-severe-hypertension-100632259","NCT07511361","Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension","A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Part Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension","KARDINAL-ASH","Key Inclusion Criteria:\n\n* Age 18 or older, body weight ≥ 50 kg with BMI ≤45.0 kg\u002Fm2\n* Ready for discharge or recently discharged from the hospital to home (within the past 7 days) during which evaluation and\u002For treatment of acute severe hypertension (documented SBP ≥ 180 mmHg and\u002For DBP ≥ 110 mmHg) occurred, as measured by a healthcare provider (HCP) within the 24 hours preceding hospitalization or during the initial 24 hours of hospitalization\n* At Screening and Randomization visit, average resting office systolic blood pressure ≥ 145 mmHg\n* Presence of established cardiovascular or renal disease\n\nKey Exclusion Criteria:\n\n* Has known history of secondary hypertension\n* Any malignancy requiring treatment within 5 years (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated)\n* Has abnormal thyroid function with clinical significance\n* Recent hospitalization for stroke, myocardial infarction or coronary revascularization within 30 days prior to screening\n* History of and\u002For obvious clinical signs or symptoms of cirrhosis or other significant liver disease\n* Alanine aminotransferase or aspartate aminotransferase \\>2 x upper limit of normal\n* Most recent hospitalization was for non-cardiovascular or non-renal conditions",{"count":199,"type":21},140,[201],"PHASE2","The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently hospitalized and concurrently experienced an episode of acute severe hypertension.",[27,204,205,206],"Acute Severe Hypertension","Hypertensive Emergency","Hypertensive Urgency","2026-06-29",{"date":209,"type":39},"2026-07-01",{"date":211,"type":39},"2026-06-23",{"date":213,"type":21},"2027-02",{"name":215,"class":80},"Kardigan, Inc.",8,{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":224,"sex":17,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":47},"100598753","integrating-free-choice-marketplace-dietitian-coaching-culturally-tailored-messaging-to-improve-blood-pressure-100598753","NCT07075588","Integrating Free-choice Marketplace, dieTitian coacHing, cultuRally Tailored messagIng to improVE Blood Pressure","iTHRIVE","Inclusion Criteria:\n\n* 21-70 years\n* Self-identify as Black\u002FAfrican American or Hispanic\u002FLatino\n* Have Stage 2 CKM defined as:\n* Systolic BP ≥130mmHg (measured at screening) AND at least one of:\n* Hypertension (ICD-10: I10-I16)\n* Prediabetes (HbA1c 5.7-6.4%) or Type 2 Diabetes (HbA1c ≥6.5%)\n* Stage 3 chronic kidney disease (CKD) (eGFR 30-59 mL\u002Fmin\u002F1.73m²)\n* Live in census tracts identified by the Montgomery\u002F Prince George's\u002FBaltimore City County Departments of Planning as HFPA:\n* Healthy Food Availability Index score is low (0-9.5),\n* Median household income ≤185% of Federal Poverty Level\n\n  * 30% of households have no vehicle,\n* Distance to supermarket \\>1\u002F4 mile. 5. Have refrigeration, food preparation appliances (microwave, stove), and cell phones for the App\n\nExclusion Criteria:\n\n* Age \\\u003C21 years\n* Diagnosis of end-stage renal disease (ESRD), dialysis\n* Serious medical condition that either limits life expectancy or requires active management (e.g., cancer)\n* Significant food allergies, preferences, intolerances, or dietary requirements that would interfere with diet adherence\n* Active alcohol or substance use disorder (i.e., not sober\u002Fabstinent for ≥ 30 days)\n* Patients with cognitive impairment or other condition preventing their participation in the intervention\n* Pregnant, breastfeeding, or planning pregnancy\n* Current participation in a care management program related to health conditions (e.g., weight reduction, smoking cessation) or another clinical trial that could interfere with the study protocol\n* Planning to move out of the geographic area in 12 months",true,"21 Years","70 Years",{"count":228,"type":21},100,[93],"iTHRIVE intervention is a 2-arm randomized controlled trial testing the effects of digital FARMacy, personalized dietitian coaching with produce prescriptions, and home blood pressure measurement in 100 hypertensive adults living in high food priority areas in counties in Maryland.",[27,232],"Hypertension Complicated With Type 2 Diabetes",[234,235,236],"Digital Farmacy","DASH Diet","Personalized dietitian coaching",{"date":181,"type":39},{"date":239,"type":39},"2026-06-25",{"date":241,"type":21},"2028-03-20",{"name":243,"class":46},"Johns Hopkins University",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100601857","streamlined-denervation-with-spyral-for-an-optimized-treatment-spyral-swyft-in-subjects-with-uncontrolled-hypertension-100601857","NCT07115953","Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension","Sub-study of SPYRAL AFFIRM: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT)","SWYFT","Inclusion Criteria:\n\n1. Individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmHg\n2. Individual has a baseline office diastolic blood pressure ≥ 90 mmHg\n3. Individual has an average systolic baseline home blood pressure ≥135 mmHg (with ≥7 days of valid pre-procedure measurements)\n4. Individual has a valid 24-hour Ambulatory Blood Pressure Measurement at baseline\n\nExclusion Criteria:\n\n1. Individual lacks appropriate renal artery anatomy\n2. Individual has undergone prior renal denervation\n3. Individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement\n4. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea\n5. Individual has an estimated glomerular filtration rate (eGFR) of \\\u003C45 mL\u002Fmin\u002F1.73m2\n6. Individual has one or more episode(s) of orthostatic hypotension\n7. Individual is pregnant, nursing or planning to become pregnant\n8. Individual has documented primary pulmonary hypertension\n9. Individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%",{"count":253,"type":21},130,[93],"The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.",[27,257,258,259,260],"Vascular Diseases","Cardiovascular Diseases","Chronic Kidney Diseases","Diabetes Mellitus",{"date":181,"type":39},{"date":75,"type":39},{"date":264,"type":21},"2029-12-31",{"name":266,"class":80},"Medtronic Vascular",21,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":115},"100645112","evaluating-the-effects-of-a-mindfulness-intervention-on-health-outcomes-in-individuals-with-hypertension-100645112","NCT07679984","Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension","Inclusion Criteria:\n\n1. Age \\>18 years old.\n2. Established patient at OSU Family Medicine\n3. Diagnosis of primary essential hypertension\n4. Ability and willingness to participate in all Mindfulness in Motion (MIM) study activities.\n5. Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.\n6. WiFi connectivity or LTE to allow use of MIM smartphone app and MyCap when not at OSU clinical site.\n\nExclusion Criteria:\n\n1. Inability to read and\u002For understand English (MIM intervention, study consent and questionnaires in English).\n2. Established mindfulness practice.\n3. Diagnosis of secondary hypertension with identifiable underlying causes including:\n\n   * Chronic kidney disease\n   * Renal artery stenosis\n   * Primary aldosteronism\n   * Cushing's syndrome\n   * Pheochromocytoma\n   * Obstructive sleep apnea\n   * Medication induced hypertension (e.g., steroids, NSAIDs)\n   * Pregnancy related hypertension\n4. Current severe alcohol or substance abuse disorder.\n5. Participants with documented cognitive disorder that limits the ability to independently participate in MIM program, read, understand, and\u002For complete the surveys; i.e. dementia, Alzheimer's or biological tests.\n6. Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.",{"count":199,"type":21},[93],"The purpose of this study is to evaluate the effectiveness of adding the Mindfulness in Motion (MIM) program to the usual primary care for people with high blood pressure. MIM is a facilitated, 8-week online program that teaches simple ways to manage stress using mindfulness practices. The program also includes the use of a companion smartphone app throughout the 12-month study period. In this study, we will compare people who receive their usual care and take part in the MIM program with those who receive usual care alone to see if it helps improve blood pressure, weight, stress, sleep, and overall well-being. Over 12 months, all participants will be asked to complete short questionnaires about stress, sleep, and resilience four times via a smartphone, tablet, or computer.",[27,278],"Essential (Primary) Hypertension",[29,280,281,282,283,284,285],"primary care","mindfulness","stress","resilience","sleep","blood pressure","2026-06-26",{"date":209,"type":39},{"date":289,"type":21},"2026-10-01",{"date":291,"type":21},"2028-05-01",{"name":293,"class":46},"Ohio State University",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":301,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":298,"conditions":305,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":308,"leadSponsor":310,"locationsCount":115},"100641759","phase-3-a-study-to-evaluate-efficacy-and-safety-of-hcp1803-4-in-patients-with-essential-hypertension-100641759","NCT07660796","A Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension","A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate Efficacy and Safety of HCP1803-4 in Patients With Essential Hypertension","Inclusion Criteria:\n\n1. Patients with essential hypertension whose blood pressure measured in visit1 corresponds to the following conditions\n\n   * mean sitSBP \\\u003C 180 mmHg and mean sitDBP \\\u003C 110 mmHg for patients receiving any BP-lowering drug within 1 month prior to Visit 1\n   * 140 mmHg ≤ mean sitSBP \\\u003C 180 mmHg and 60 mmHg ≤ mean sitDBP \\\u003C 110 mmHg for patients not receiving BP-lowering drugs within 1 month prior to Visit 1\n2. Patients with essential hypertension who meet 140 mmHg ≤ mean sitSBP \\\u003C 180 mmHg and 60 mmHg ≤ mean sitDBP \\\u003C 110 mmHg at Visit 2\n\nExclusion Criteria:\n\n1. Difference between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP at Visit 1\n2. Patients who have taken more than three components of Blood pressure medication within 3 months prior to Visit 1\n3. Orthostatic hypotension with symptoms within 3 months prior to visit 1\n4. Secondary hypertensive patient or suspected to be\n5. Clinically significant hematological finding\n6. Severe heart disease or severe neurovascular disease\n7. Moderate or malignant retinopathy\n8. Uncontrolled diabetes mellitus or type I diabetes mellitus\n9. Active gout or hyperuricemia\n10. Severe renal diseases\n11. Severe or active hepatopathy\n12. Hypokalemia or Hyperkalemia\n13. Hyponatremia or Hypernatremia\n14. Hypercalcemia\n15. History of malignancy tumor\n16. History of autoimmune disease\n17. History of alcohol or drug abuse\n18. Positive to pregnancy test, nursing mother, intention on pregnancy\n19. Considered by investigator as not appropriate to participate in the clinical study with other reason","19 Years",{"count":303,"type":21},256,[59],[27],{"date":181,"type":39},{"date":151,"type":21},{"date":309,"type":21},"2027-11-30",{"name":311,"class":80},"Hanmi Pharmaceutical Company Limited",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":224,"sex":17,"minAge":320,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":325,"conditions":326,"keywords":330,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":115},"100639438","uppsala-self-screening-of-cardiovascular-health-100639438","NCT07614659","Uppsala Self-Screening of Cardiovascular Health","Uppsala Self-Screening of Cardiovascular Health: A Randomized Controlled Trial of Home-Based Multimodal Cardiovascular Screening Versus Usual Care in Middle-Aged and Older Adults","U-SCREEN","Inclusion Criteria:\n\n* Resident in Region Uppsala, Sweden\n* Turning 50, 55, 60, 65, 70 or 75 years during recruitment period\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Protected identity","50 Years","75 Years",{"count":323,"type":21},45000,[93],"U-SCREEN is a randomized controlled trial evaluating whether systematic home-based multimodal screening for cardiovascular risk conditions, offered to residents in Region Uppsala turning 50, 55, 60, 65, 70 or 75 years of age, can identify clinically actionable cardiovascular risk factors more effectively than usual care. Participants randomized to the screening arm receive a home blood pressure measurement device, a dried blood spot sampling kit (for ApoB, HbA1c and creatinine), and a digital questionnaire. The control arm receives usual care. Recruitment runs 2024-2027 with a target identification of 10,000 cardiovascular risk conditions.",[258,27,327,260,328,329],"Dyslipidemias","Atrial Fibrillation","Chronic Kidney Disease",[331,332,333,334,335,336,337],"Population screening","Cardiovascular prevention","Home blood pressure monitoring","Dried blood spot","Digital health","Pragmatic trial","Register-based randomized controlled trial",{"date":181,"type":39},{"date":340,"type":39},"2025-02-01",{"date":342,"type":21},"2037-12",{"name":344,"class":46},"Johan Sundström",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":224,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100645220","llm-assisted-diabetes-and-hypertension-management-by-village-doctors-100645220","NCT07678658","LLM-Assisted Diabetes and Hypertension Management by Village Doctors","Large Language Model-Assisted Decision Support for Improving Village Doctors' Integrated Management of Patients With Type 2 Diabetes and Hypertension: A Randomized Controlled Study","Inclusion Criteria:\n\n1. Certified village doctors or primary care physicians practicing in rural primary healthcare institutions;\n2. At least 1 year of experience in the management of chronic diseases, including type 2 diabetes mellitus and hypertension;\n3. Able to complete the case assessment tasks required by the study;\n4. Willing to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\nNone.","80 Years",{"count":354,"type":21},20,[93],"This is a prospective, assessor-blinded, randomized controlled study designed to evaluate whether large language model (LLM)-assisted decision support can improve village doctors' abilities in the comprehensive management of patients with type 2 diabetes mellitus and hypertension.\n\nFor each standardized clinical case, two village doctors will independently review the same patient information and develop management plans. An independent statistician will randomly assign one doctor to receive LLM-assisted decision support, while the other will complete the assessment without assistance. All management plans and questionnaire responses will be de-identified and evaluated by an independent expert panel blinded to group allocation. The study will compare the quality of clinical decision-making, risk assessment, treatment recommendations, and follow-up planning between the LLM-assisted and control groups.",[358,27],"Type 2 Diabetes Mellitus",{"date":209,"type":39},{"date":209,"type":21},{"date":362,"type":21},"2026-07-14",{"name":364,"class":46},"Jiangsu Taizhou People's Hospital",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":224,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":374,"phases":4,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":386,"locationsCount":115},"100644470","community-blood-pressure-screening-and-cardiovascular-risk-assessment-in-croatia-100644470","NCT07670741","Community Blood Pressure Screening and Cardiovascular Risk Assessment in Croatia","A Prospective Observational Study of Blood Pressure Values, Antihypertensive Medication Use and Cardiovascular Risk Factors Among Adults Attending Community-Based Public Health Screening Campaigns in Croatia","BPSCREEN-CRO","Inclusion Criteria:\n\n* Age 18 years or older\n* Voluntary attendance at a community-based public health blood pressure screening campaign\n* Ability to understand the study information\n* Signed informed consent for participation in the baseline observational study\n\nExclusion Criteria:\n\n* Age under 18 years\n* Inability or unwillingness to provide informed consent\n* Incomplete baseline blood pressure data preventing assessment of the primary outcome\n* Acute medical condition requiring immediate emergency evaluation before completion of study procedures, at the discretion of the research team",{"count":125,"type":21},"OBSERVATIONAL","This is a prospective, observational, non-interventional study conducted during community-based public health blood pressure screening campaigns in Croatia. Adult participants who voluntarily attend public health actions will be invited to complete a short questionnaire on demographics, known cardiovascular risk factors, medical history and medication use. Blood pressure and pulse will be measured using validated blood pressure monitors. The study will assess the prevalence of elevated blood pressure, known and potentially undiagnosed hypertension, antihypertensive treatment patterns and cardiovascular risk factors. Participants may optionally consent to short-term follow-up by telephone or e-mail after 1 to 3 months to collect information on repeated blood pressure measurement, physician consultation, additional evaluation, new diagnosis of hypertension or medication change. The study does not include treatment allocation, prescribing or modification of therapy by the research team.",[27,377],"Cardiovascular Risk Factors",[379,380,381],"blood pressure screening","public health campaign","antihypertensive medication",{"date":207,"type":39},{"date":185,"type":21},{"date":385,"type":21},"2028-07-15",{"name":387,"class":46},"Dr. Josip Benčević General Hospital",{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":17,"minAge":320,"maxAge":321,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":409,"leadSponsor":411,"locationsCount":167},"100645080","polypills-approach-for-multiple-cardiovascular-risk-factors-100645080","NCT07679828","Polypills Approach for Multiple Cardiovascular Risk Factors","Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial","PACIF","Inclusion Criteria:\n\n* Men or women\n* Age ≥50 years and \\\u003C75 years\n* Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication\n* Dyslipidemia, defined as LDL-C ≥1.8 mmol\u002FL (70 mg\u002FdL)\n* Type 2 diabetes with HbA1c ≥6.5% and \\\u003C12%\n* Willing to participate and able to sign informed consent\n\nExclusion Criteria:\n\n* Known secondary cause of hypertension\n* Type 1 diabetes\n* Pancreatic insufficiency or diabetes secondary to pancreatitis\n* Triglycerides ≥5.65 mmol\u002FL (500 mg\u002FdL)\n* History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months\n* History of myocardial infarction or stroke within the previous 6 months\n* NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months\n* Abnormal kidney function, defined as estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis\n* Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal\n* Abnormal serum potassium, defined as serum potassium \\>5.5 mmol\u002FL or \\\u003C3.5 mmol\u002FL\n* Contraindication to any of the components of the polypill\n* Currently living with another PACIF participant\n* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control\n* Clinical diagnosis of dementia or treatment with medications for dementia\n* History of malignancy\n* Life expectancy \\\u003C3 years\n* Currently participating in another intervention study\n* Any factors judged by the clinic team to be likely to limit adherence to interventions",{"count":397,"type":21},8252,[93],"The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.",[27,401,96],"Dyslipidemia",[27,401,96,403,404,258,405,406],"Polypill","Cardiovascular disease risk","Cognitive function","Randomized controlled trial",{"date":209,"type":39},{"date":209,"type":21},{"date":410,"type":21},"2030-03-01",{"name":412,"class":46},"China Medical University, China",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":420,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":115},"100635557","auricular-acupuncture-therapy-administered-by-village-doctors-improves-sleep-quality-in-elderly-patients-with-comorbid-diabetes-mellitus-and-hypertension-100635557","NCT07554235","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension","Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes and Hypertension","Inclusion Criteria:\n\n1. Age ≥65 years;\n2. Patients with comorbid diabetes mellitus and hypertension:\n3. Sleep disturbance: Pittsburgh Sleep Quality Index (PSQI) total score ≥8;\n4. Willing to participate in this study and sign the informed consent form;\n5. Has resided in this village for at least six months.\n\nExclusion Criteria:\n\n1. Stroke;\n2. Severe mental illness or cognitive impairment;\n3. Severe organ failure (e.g., end-stage renal disease);\n4. Ear infection, eczema, breakage, or deformity;\n5. Currently receiving regular other acupuncture treatments;\n6. Use of any hypnotic medications within the past month\n7. Bleeding disorders or use of anticoagulants (increased bleeding risk);\n8. History of fainting during acupuncture;\n9. Life expectancy less than six months.","65 Years",{"count":422,"type":21},320,[93],"This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village doctor-led intervention model supported by telemedicine can improve sleep disturbances in patients with comorbid diabetes mellitus and hypertension, compared to sham auricular press-needle acupuncture. Participants will be recruited by local village doctors according to the inclusion and exclusion criteria. The protocol is based on Traditional Chinese Medicine theory for core point selection: Heart, Liver, Kidney, Shenmen, and Forehead area, along with optimized medication regimens supported by remote cardiovascular specialists. The investigators will evaluate the overall improvement in sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at the end of the 6-week treatment period, and assess sleep disturbances, anxiety, depression, daytime sleepiness, and fatigue at 12 weeks.",[426,96,27],"Insomnia Disorder",[428,429,27,96,430],"Village Doctors","Acupuncture needles","insomnia",{"date":207,"type":39},{"date":433,"type":39},"2026-04-22",{"date":435,"type":21},"2027-02-20",{"name":364,"class":46},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":17,"minAge":445,"maxAge":321,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":458},"100559112","thrive--therapeutic-intravascular-ultrasound-tivus-renal-denervation-system-versus-sham-for-the-adjunctive-treatment-of-hypertension-100559112","NCT06559891","THRIVE- THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension","A Pivotal, Prospective, Multicenter, 2:1 Randomized, Double Blind, Controlled, Study Comparing the THerapeutic IntravasculaR Ultrasound (TIVUS™) REnal Denervation System Versus Sham for the Adjunctive Treatment of Hypertension (The THRIVE Study)","THRIVE","Inclusion Criteria:\n\n1. Appropriately signed and dated informed consent\n2. Male and female adults with age between ≥22 and ≤75 years at time of consent\n3. Documented history of hypertension\n4. Previously or currently prescribed antihypertensive therapy\n5. Subject has an office BP (average of 3 seated measurements) of:\n\n   1. Uncontrolled BP: ≥ 140\u002F90 mmHg \\\u003C180\u002F110 mmHg at Screening Visit (V0) while stable for at least 4 weeks on 0-2 anti-hypertensive medications of different classes\\* and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure, (subjects with a history of treatment with anti-hypertensive medications but are not currently taking any at screening will undergo a 4-week run-in period) or,\n   2. Controlled BP: \\\u003C 140\u002F90 mmHg while stable for at least 4 weeks on 1-2 antihypertensive medications of different classes and willing to stop anti-hypertensive medication(s) for 4 weeks wash-out and 2-months post-procedure\n6. Able and willing to comply with all study procedures\n7. Subject is willing to have and is a good candidate for conscious sedation\n\nSubjects who meet the following criteria will be considered eligible for randomization:\n\n* Documented daytime systolic ABP ≥ 135 mmHg and \\\u003C 180 mmHg after 4-week washout\u002Frun-in period.\\*\\*\n* Suitable renal anatomy compatible with the renal denervation procedure, documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in subjects without a recent (≤1 year) cross-sectional renal imaging). The renal angiogram procedure done in the cath lab prior to randomization will serve as the final anatomy compatibility check.\n\n  * Potassium-sparing diuretics such as Amiloride hydrochloride and Triamterene may be prescribed in combination with another diuretic (e.g. a thiazide or loop diuretic) for their potassium conservation properties. In this situation, the diuretic combination is considered as a single class of anti-hypertensive.\n\nExclusion Criteria:\n\n1. Subject has been previously diagnosed with abnormal renal artery anatomy and\u002For renal anatomy such as a single kidney, ectopic or horseshoe kidney, polycystic kidney disease, kidney tumors or other findings precluding renal denervation therapy as detailed in the angiographic exclusion criteria\n2. Uncorrected causes of secondary hypertension other than sleep apnea (including, but not limited to): aldosteronism, renal parenchymal disease, renovascular disease, excess catecholamines, Cushing's syndrome, erythropoietin use, pheochromocytoma, hypo\u002Fhyperthyroidism, hyperparathyroidism, acromegaly)\n3. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma HbA1c ≥ 9.0%)\n4. eGFR of \\\u003C40 mL\u002Fmin\u002F1.73 m2 CKD-EPI as calculated using the CKD-EPI 2021 equation\n5. Cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) within 6 months prior to consent\n6. History of severe cardiovascular event (e.g. myocardial infarction, unstable angina, CABG, acute heart failure requiring hospitalization (NYHA III-IV) within 12 months prior to consent\n7. Subject has severe valvular stenosis or insufficiency\n8. Documented repeat (\\>1) hospitalization for hypertensive crisis within the prior 12 months and\u002For any hospitalization for hypertensive crisis within three (3) months prior to consent\n9. Prescribed to any standard antihypertensive cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health in the opinion of the investigator\n10. Subject with rapid, uncontrolled, symptomatic atrial fibrillation\n11. Active implantable medical device (e.g. ICD or CRT-D; neuromodulator\u002Fspinal stimulator; baroreflex stimulator)\n12. Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.\n13. Subject has a planned major surgery (any procedure requiring general anesthesia) in the next 12 months.\n14. Subject on anticoagulant therapy that cannot be temporarily withheld for study procedure.\n15. Primary pulmonary hypertension\n16. Documented contraindication or allergy to contrast medium not amenable to treatment\n17. Limited life expectancy of \\\u003C 1 year at the discretion of the Investigator\n18. Night shift worker\n19. Subject has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.\n20. Subject is taking immunosuppressive therapy for diseases featuring vasculitis\n21. Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or for any reason in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements or whose participation may result in data analysis confounders\n22. Pregnant, nursing or planning to become pregnant within 12 months post procedure.\n\n    Negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of childbearing potential. Documentation of effective contraception is also required for women of childbearing potential\n23. Subject has a planned major surgery or cardiovascular intervention in the next 6 months\n24. Subject with history of renal transplantation\n25. Evidence of active infection within 7 days of procedure (based on positive lab test and requiring therapy).\n26. Subject has hypertrophic cardiomyopathy or amyloidosis.\n27. Prior renal denervation procedure\n28. Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional studies\u002Fregistries is acceptable)\n29. Subject on a beta blocker for a condition other than antihypertension\n\nAngiographic Exclusion Criteria:\n\nThe following characteristics identified either on the renal artery CT scan or MRI or on the Eligibility II Renal artery Angiogram will prevent the subject from being included:\n\n1. Main renal arteries lumen diameter \\\u003C 4 mm.\n2. Main renal treatable artery length \\\u003C20mm (may include proximal branching).\n3. Accessory renal arteries that supplies ≥ 25% of the parenchyma, and \\\u003C 4 mm in lumen diameter.\n4. Aorto-renal angle that prevents a safe cannulation of the renal artery.\n5. Severe common femoral artery, common and\u002For external iliac artery, renal, iliac or aortic calcification or tortuosity that may compromise the safe performance and completion of the TIVUS™ procedure.\n6. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, would interfere with safe cannulation of the renal artery or meets local standards for surgical repair or interventional dilation (NOTE: vessel areas with calcification and fibromuscular dysplasia (FMD) should be avoided as intended treatment areas).\n7. Any renal artery stenosis \\> 30% by visual assessment.\n8. Any renal artery aneurysm (\\>50% of the main renal artery reference vessel diameter by visual estimate).\n9. Presence of fibromuscular dysplasia of the renal arteries\n10. Significant renal artery atheroma, aneurysm, calcification in the target vessel identified on CT Angiogram","22 Years",{"count":447,"type":21},261,[93],"The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in:\n\n1. subjects with uncontrolled hypertension (HTN) receiving 0 - 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN\u002FSham procedure and during 2 months after procedure.\n2. subjects with controlled hypertension receiving 1 - 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN\u002FSham procedure and 2 months after the procedure",[27],{"date":181,"type":39},{"date":453,"type":39},"2024-10-03",{"date":455,"type":21},"2028-08-15",{"name":457,"class":80},"SoniVie Inc.",50,{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":374,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":473,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":480},"100547053","clevidipine-for-the-antihypertensive-treatment-of-acute-intracerebral-hemorrhage-100547053","NCT06402968","Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage","CLUTCH","Inclusion Criteria\n\n1. Age 18 years or older and less than 100 years.\n2. Onset of new neurological deficits within 12 hours at the time of enrollment and IV clevidipine or alternate IV antihypertensive regimen can be initiated within 12 hours of symptom onset.\n3. Clinical signs consistent with the diagnosis of stroke, including impairment of language, motor function, cognition, and\u002For gaze, vision, or neglect.\n4. Initial National Institutes of Health Stroke Scale (NIHSS) score of 1 or greater.\n5. Total GCS score (aggregate of verbal, eye, and motor response scores) of 5 or greater at enrollment\n6. Computed Tomography (CT) scan of the brain demonstrates intraparenchymal hematoma with manual hematoma volume measurement \\>5 cc (excluding microhemorrhages)\n7. Admission SBP greater than and equal to 150 mmHg but less than 220 mmHg on two repeat measurements at least 5 minutes apart, but no more than 10 minutes apart. The reason for exclusion of ICH patients with initial SBP ≥220 mm Hg is based on a post hoc analysis of ATACH-2, which found that patients with initial SBP ≥220 mm Hg (22.8% of the cohort) reported higher rates of neurological deterioration at 24 hours and renal adverse events until day 7 or discharge in patients treated with intensive SBP reduction compared with standard SBP lowering, without any benefit in reducing hematoma expansion at 24 hours or death or severe disability at 90 days.\n8. Signed and dated informed consent by subject, legally authorized representative, or surrogate before index hospital discharge for data collection and agreement to participate in 90- and 180-day follow-up visits.\n9. Patients with anticoagulant-related ICH are eligible as long as anticoagulant reversal is concurrently undertaken consistent with AHA\u002FASA guidelines.\n10. Patients who will undergo surgical evacuation consistent with AHA\u002FASA guidelines or local institutional guidelines are eligible unless surgical evacuation is being performed within 6 hours of initiation of IV clevidipine or alternate IV antihypertensive medication regimen. Ultra-early surgery will necessitate use of anesthetic agents which will confound the effect of IV clevidipine or alternate IV antihypertensive medication regimen. Ultra-early surgery\u002Fintervention was not used in the minimally invasive catheter evacuation followed by thrombolysis (MISTIE)\u002F Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (CLEAR) trials, which required ICH patients to undergo a repeat CT scan after 6 hours to document absence of any hematoma expansion (with ≤5 mL hematoma growth) compared to a previous CT scan prior to any surgical intervention.\n11. Patients requiring external ventricular drainage consistent with AHA\u002FASA guidelines or local institutional guidelines are eligible.\n\nExclusion Criteria\n\n1. Time of symptom onset cannot be reliably assessed.\n2. Previously known neoplasms, arteriovenous malformation (AVM), or aneurysms.\n3. Intracerebral hematoma considered to be related to trauma.\n4. ICH located in infratentorial regions such as pons or midbrain (cerebellar ICH is not an exclusion criteria).\n5. Subject considered a candidate for immediate surgical intervention by the neurosurgery service.\n6. Pregnancy, parturition within previous 30 days, or active lactation.\n7. Any history of bleeding diathesis or coagulopathy except anticoagulant related ICH.\n8. Platelet count of less than 50,000\u002Fmm3.\n9. Known sensitivity to nicardipine or clevidipine.\n10. Patient's living will precludes aggressive ICU management.\n11. Patients with allergies to soybeans, soy products, eggs, or egg products.\n12. Defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia.\n13. Patients with severe aortic stenosis.","100 Years",{"count":468,"type":21},1000,"The 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.",[471,472,27],"Intracerebral Hemorrhage","Stroke",{"date":286,"type":39},{"date":475,"type":39},"2024-06-01",{"date":477,"type":21},"2028-07-30",{"name":479,"class":46},"Zeenat Qureshi Stroke Institute",16,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":489,"studyType":374,"phases":4,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":499,"locationsCount":501},"100639457","impact-htn-study-of-patients-with-hypertension-100639457","NCT07579260","IMPACT-HTN Study of Patients With Hypertension","Prospective Early Patient Experience Initiative (IMPACT-HTN)","Inclusion Criteria:\n\n* Signed and dated informed consent form\n* Ability to answer survey questions and to report blood pressure reading monthly\n* Male and female participants; 18 years or older\n* Treated with at least 2 antihypertensive therapies of different pharmacological classes for at least 4 weeks before the screening visit\n* Mean Sitting Systolic Blood Pressure (SiSBP) greater or equal to 130 mmHg\n\nExclusion Criteria:\n\n* Confirmed severe hypertension (grade 3) defined as SiSBP greater than or equal to 180 mmHg and\u002For Sitting Diastolic Blood Pressure (SiDBP) greater than or equal to 110 mmHg\n* Clinically significant unstable cardiac disease at screening or in the past in the opinion of the investigator\n* Heart failure NYHA functional class III and IV or NT-proBNP \\> 500 pg\u002FmL\n* Severe renal insufficiency or eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m2\n* Moderate to severe hepatic impairment (Child-Pugh B and C) or elevated aminotransferase (\\> 3 x ULN)",{"count":228,"type":21},"97 Days","An estimated 120 million people have high blood pressure (hypertension) in the US, of which approximately 10% have resistant hypertension. This study aims to enroll patients who continue to have hypertension while being treated with at least two medications. The study will follow patients for approximately 3 months and collect real-world information on changes in their health to identify an ideal patient profile that would benefit from 4th-line antihypertensive therapies, including, but not limited to, FDA-approved aprocitentan, renal denervation, mineralocorticoid receptor antagonists, etc.",[492,27,493],"Hypertension (HTN)","Blood Pressure, High","2026-06-24",{"date":207,"type":39},{"date":209,"type":21},{"date":498,"type":21},"2027-04-01",{"name":500,"class":46},"Vivek Bhalla",2,{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":224,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":511,"studyType":374,"phases":4,"briefSummary":512,"conditions":513,"keywords":517,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":4},"100644912","faisalabad-initiative-of-research-and-management-of-ncds-100644912","NCT07676214","Faisalabad Initiative of Research and Management of NCDs","FIRM-NCD","Inclusion Criteria:\n\nAge: 18 years and above Gender: Both male and female Permanent residents of the selected study areas Willing to participate and provide informed consent\n\nExclusion Criteria:\n\nPregnant and lactating women Oral and injectable contraceptive users Individuals with severe physical or cognitive impairments that prevent them from providing informed consent or participating in the screening procedures Individuals with implanted electronic medical devices (e.g., pacemakers or implantable cardioverter-defibrillators) will not undergo bioelectrical impedance analysis (BIA) for body composition assessment.",{"count":510,"type":21},3000,"3 Months","The burden of noncommunicable diseases (NCDs) continues to rise globally, and they have become the leading cause of morbidity and mortality, accounting for over 70% of deaths worldwide¹. Rapid lifestyle transitions and increasing urbanization have disproportionately affected low- and middle-income countries, which now bear a substantial share of the global NCD burden.\n\nPakistan, with a population of 241.5 million, is experiencing a double burden of both communicable diseases and NCDs¹³. The widespread adoption of sedentary lifestyles and unhealthy dietary patterns has contributed to a marked increase in NCDs across the country².\n\nAccording to the WHO Hypertension profile 2025, it is the most prevalent NCD in Pakistan, affecting approximately 42% (41% males and 44% females) of the population¹¹, followed by diabetes, with a reported prevalence of 30.8%¹². Additionally, a recent cross-sectional study among adults attending a tertiary care hospital in Islamabad reported dyslipidemia in 71.6% of men and 78.4% of women, indicating a substantial underlying community burden³. Pakistan also ranks tenth among 188 countries in terms of overweight and obesity prevalence, with nearly half of its population classified as overweight or obese⁴. According to World Health Organization data, 58.1% of Pakistanis are overweight, and 43.9% fall within the obese category⁴.\n\nDespite their profound public health and economic implications, efforts to address NCDs remain fragmented and insufficient.17 There remains a significant research gap in community-based NCD screening initiatives, particularly within the suburban and peri-urban communities of Faisalabad creating an unmet need to initiate a preventive strategy at community level to raise awareness about these diseases. This direction will minimize the increasing incidence and prevalence of NCDs and will ensure the quality health outcomes for better future.\n\nTimely identification of these diseases through screening is a critical step in reducing their impact on individuals and societies. Early detection enables cost-effective management, improved patient outcomes and a higher quality of life.14 One of the most important ways of reducing deaths from noncommunicable diseases (NCDs) is to control the risk factors that lead to their development.6 In this context, the present study aims to evaluate a community-based project focusing on disease awareness, screening, and structured referral to trained treating physicians for early diagnosis and management of major NCDs. The findings are expected to inform scalable, evidence-based interventions to reduce NCD burden and improve population health outcomes in Pakistan.",[514,27,515,516],"Diabete Mellitus","Hypercholerolemia","Obesity (Disorder)",[518,96,27,101,519],"community screening","Hypercholestrolemia",{"date":181,"type":39},{"date":522,"type":21},"2026-08-01",{"date":524,"type":21},"2027-12-31",{"name":526,"class":80},"Getz Pharma",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":420,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":545,"leadSponsor":547,"locationsCount":4},"100644150","safety-and-efficacy-of-renal-denervation-for-untreated-grade-i-hypertension-a-pilot-study-100644150","NCT07664787","Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study","Safety and Efficacy of Six-Channel Radiofrequency Ablation System for Renal Denervation in Patients With Untreated Grade I Hypertension: a Pilot Study","STAR","Inclusion Criteria:\n\n1. Male or female, aged 18 to 65 years inclusive\n2. Hypertension duration longer than 3 months\n3. Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic\u002Fdiastolic blood pressure still ≥140\u002F90 mmHg and \\\u003C160\u002F100 mmHg, and 24-hour ambulatory mean systolic \u002Fdiastolic pressure ≥130\u002F80 mmHg and \\\u003C140\u002F90 mmHg;\n4. The subject or his\u002Fher legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or planning pregnancy during the study.\n2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \\\u003C3 mm, or treatable segment length \\\u003C20 mm).\n3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR\\\u003C40mL\u002Fmin\u002F1.73m2。\n4. Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma\u002Fparaganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.).\n5. Allergic to contrast agents.\n6. Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months.\n7. Orthostatic hypotension.\n8. Type 1 diabetes mellitus.\n9. History of bleeding diathesis and haematological disorders or coagulopathy\n10. History of thromboembolic event within 6 months.\n11. History of stroke or transient ischemic attack (TIA) within 6 months.\n12. Severe peripheral arterial disease or unstable abdominal aortic aneurysm.\n13. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III\u002FIV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months.\n14. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.\n15. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.\n16. Acute or severe systemic infection.\n17. Other conditions deemed unsuitable for participation by the investigator.",{"count":354,"type":21},[93],"Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.",[27,539],"Grade 1",[29,541,542],"renal denervation","grade I",{"date":494,"type":39},{"date":209,"type":21},{"date":546,"type":21},"2027-12-30",{"name":548,"class":46},"Ruijin Hospital",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100597898","phase-3-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-100597898","NCT07064473","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","EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":557,"type":21},11800,[59],"This 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.\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants 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.",[561,27,258],"Diabetes Mellitus, Type 2",{"date":494,"type":39},{"date":564,"type":39},"2025-07-22",{"date":566,"type":21},"2029-12-21",{"name":568,"class":80},"Boehringer Ingelheim",1155,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":578,"targetDuration":4,"studyType":22,"phases":580,"briefSummary":581,"conditions":582,"keywords":583,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":144},"100585805","spyral-gemini-pilot-study-100585805","NCT06907147","SPYRAL GEMINI Pilot Study","Global Pilot Study of rEnal and Hepatic coMbINed denervatIon in Subjects With Uncontrolled Hypertension With and Without High Cardiovascular Risk","SPYRAL GEMINI","Inclusion Criteria:\n\nAll Subjects (both cohorts):\n\n1. ≥18 and ≤80 years of age.\n2. Diagnosed with HTN and has a baseline office SBP ≥150 mmHg and \\\u003C180 mmHg and an office DBP ≥ 90 mmHg.\n3. 24-hour average SBP ≥140 mmHg and \\\u003C170 mmHg measured by ABPM at Baseline.\n\nExclusion Criteria:\n\n1. Individual lacks appropriate renal artery OR common hepatic artery anatomy.\n2. Prior renal or hepatic denervation.\n3. History of NYHA Class III or IV heart failure within 6 months of screening visit.\n4. Stroke or transient ischemic attack (TIA) within 6 months of screening visit or any history of stroke leading to permanent disability.\n5. Documented Type 1 diabetes or use of insulin within 6 months.\n6. Secondary cause of hypertension.\n7. Documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement.\n8. Estimated glomerular filtration rate (eGFR) of \\\u003C40\n9. Pregnant, nursing or planning to become pregnant during the study.\n10. Primary pulmonary arterial hypertension.\n11. History or evidence of active \u002F suspected chronic liver or biliary disease.\n12. Current or chronic pancreatitis.",{"count":579,"type":21},175,[93],"The 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.",[27,257,258,259,260],[584,106,585,586,587,27,258,257,588,589,590],"Renal Insufficiency","Disease Attributes","Pathologic Processes","Kidney Diseases","Denervation","Renal Denervation","Hepatic Denervation","2026-06-22",{"date":494,"type":39},{"date":594,"type":39},"2025-05-01",{"date":596,"type":21},"2029-12-22",{"name":266,"class":80},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":89,"minAge":18,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":115},"100634473","the-reach-out-trial-100634473","NCT07540143","The REACH-OUT Trial","A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial","Inclusion Criteria:\n\n* biologically female\n* age 18-44\n* English or Spanish-speaking\n* prescribed an antiHTN\n* have a systolic BP \\>140 or diastolic BP\\>90 at their index visit\n* have access to the internet\n\nExclusion Criteria:\n\n* not pregnant or within 3 months postpartum\n* severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation","44 Years",{"count":607,"type":21},350,[93],"Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.",[27,611,612,613],"Reproductive Behavior","Primary Health Care","Electronic Health Record","2026-06-18",{"date":591,"type":39},{"date":617,"type":39},"2026-06-16",{"date":619,"type":21},"2030-06-30",{"name":135,"class":46},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":628,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":115},"100603360","early-time-restricted-eating-in-older-adults-with-hypertension-100603360","NCT07135505","Early Time-Restricted Eating in Older Adults With Hypertension","The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window","Inclusion Criteria:\n\n* Consent to participate in the study\n* Men and women ≥ 60 years old\n* Average office systolic BP ≥130 mmHg\n* Self-reported ≥12 hours eating period per day of at least 5 days\u002Fweek\n* Stable health history over the past 2 months\n\nExclusion Criteria:\n\n* Fasting \\>12 hours per day\n* Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake\n* Have lost ≥ 10 pounds in last 3 months\n* Unable to wake up at a regular time between 6-8 am\n* Perform overnight shift work more than 1day\u002Fweek on average\n* Resting heart rate of \\>120 beats per minute, systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure of \\> 100 mmHg\n* Have been diagnosed with diabetes\n* On insulin or diabetes medication\n* Unstable angina, heart attack or stroke in the past 3 months\n* Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure\n* Pregnant or breastfeeding\n* Rheumatoid arthritis, Parkinson's disease or currently on dialysis\n* Current diagnosis of a major psychiatric condition that would impair study participation\n* Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease\n* Active treatment for cancer in the past year\n* Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)","60 Years",{"count":20,"type":21},[93],"The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.",[27,633],"Eating Behaviors",{"date":591,"type":39},{"date":636,"type":39},"2026-02-16",{"date":638,"type":21},"2028-07-31",{"name":640,"class":46},"University of Alabama at Birmingham"]