[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100320848":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":198,"collaborators":24,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":24,"enrollmentInfo":211,"targetDuration":24,"studyType":214,"phases":215,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},{"fullName":5,"class":6},"University of Vigo","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive asleep SBP control","ACTIVE_COMPARATOR","To reduce the asleep SBP mean up to a target \\\u003C110 mmHg. Treatment of elevated asleep SBP mean",[13],"Procedure: Treatment of elevated asleep SBP mean",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional asleep SBP control","To reduce the asleep SBP mean up to a target \\\u003C120 mmHg. Treatment of elevated asleep SBP mean",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Treatment of elevated asleep SBP mean","To reduce asleep SBP mean determined by 48h ambulatory blood pressure monitoring up to the randomly assigned target by hypertension treatment intensification when required",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Ramon C Hermida, PhD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","34986812148","rhermida@uvigo.es",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"José R Fernández, PhD","34986812146","jramon.fernandez@uvigo.es",[39,59,84,103,118,131,143,155,170],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Complexo Hospitalario Universitario de Ourense","RECRUITING","Ourense","Orense","32005","Spain","ES",{"type":48,"coordinates":49},"Point",[50,51],-7.86407,42.33669,{"lat":51,"lon":50},[54,58],{"name":55,"role":31,"phone":56,"phoneExt":24,"email":57},"Alfonso Otero, MD, PhD","34988385625","Alfonso.Otero.Gonzalez@sergas.es",{"name":55,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":60,"status":41,"city":61,"state":62,"zip":63,"country":45,"countryCode":46,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"CS A Estrada","A Estrada","Pontevedra","26680",{"type":48,"coordinates":65},[66,67],-8.48842,42.68911,{"lat":67,"lon":66},[70,74,76,78,80,82],{"name":71,"role":31,"phone":72,"phoneExt":24,"email":73},"Juan J Sánchez Castro, MD","34986573459","juanjose.sanchez.castro@sergas.es",{"name":75,"role":31,"phone":24,"phoneExt":24,"email":24},"Juan J Sanchez Castro, MD",{"name":77,"role":31,"phone":24,"phoneExt":24,"email":24},"Mariana Carbon, MD",{"name":79,"role":31,"phone":24,"phoneExt":24,"email":24},"Maria C Garcia, MD",{"name":81,"role":31,"phone":24,"phoneExt":24,"email":24},"Francisco Romero, MD",{"name":83,"role":31,"phone":24,"phoneExt":24,"email":24},"Maria P Brea",{"facility":85,"status":41,"city":86,"state":62,"zip":87,"country":45,"countryCode":46,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"CS Panxón","Nigrán","36340",{"type":48,"coordinates":89},[90,91],-8.80656,42.14153,{"lat":91,"lon":90},[94,98,99,101],{"name":95,"role":31,"phone":96,"phoneExt":24,"email":97},"Jose L Salgado, MD","34986368615","joseluis.salgado.conde@sergas.es",{"name":95,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":100,"role":31,"phone":24,"phoneExt":24,"email":24},"Esperanza Parrado",{"name":102,"role":31,"phone":24,"phoneExt":24,"email":24},"Alfredo Pereira",{"facility":104,"status":41,"city":105,"state":62,"zip":106,"country":45,"countryCode":46,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Centro de Salud de A Doblada","Vigo","36205",{"type":48,"coordinates":108},[109,110],-8.72264,42.23282,{"lat":110,"lon":109},[113,117],{"name":114,"role":31,"phone":115,"phoneExt":24,"email":116},"María T Ríos, MD, PhD","34986275121","rios.rey@mundo-r.com",{"name":114,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":119,"status":41,"city":105,"state":62,"zip":120,"country":45,"countryCode":46,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Centro de Salud de Bembrive","36214",{"type":48,"coordinates":122},[109,110],{"lat":110,"lon":109},[125,129],{"name":126,"role":31,"phone":127,"phoneExt":24,"email":128},"Juan J Crespo Sabarís, MD, PhD","34986424636","juanjose.crespo.sabaris@sergas.es",{"name":130,"role":31,"phone":24,"phoneExt":24,"email":24},"Juan J Crespo Sabaría, MD, PhD",{"facility":132,"status":41,"city":105,"state":62,"zip":120,"country":45,"countryCode":46,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"Centro de Salud de Sardoma",{"type":48,"coordinates":134},[109,110],{"lat":110,"lon":109},[137,141],{"name":138,"role":31,"phone":139,"phoneExt":24,"email":140},"Manuel Domínguez-Sardiña, MD, PhD","34986416324","manuel.dominguez.sardina@sergas.es",{"name":142,"role":31,"phone":24,"phoneExt":24,"email":24},"Manuel Domínguez, MD, PhD",{"facility":144,"status":41,"city":105,"state":62,"zip":145,"country":45,"countryCode":46,"cosmosGeoPoint":146,"geoPoint":148,"contacts":149},"CS Teis","36216",{"type":48,"coordinates":147},[109,110],{"lat":110,"lon":109},[150,154],{"name":151,"role":31,"phone":152,"phoneExt":24,"email":153},"Pedro A Callejas, MD","34986374229","PedroAntonio.Callejas.Cabanillas@sergas.es",{"name":151,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":156,"status":41,"city":105,"state":62,"zip":157,"country":45,"countryCode":46,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Bioengineering & Chronobilogy Labs., University of Vigo","36310",{"type":48,"coordinates":159},[109,110],{"lat":110,"lon":109},[162,163,164,166,168],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},{"name":27,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":165,"role":31,"phone":24,"phoneExt":24,"email":24},"Artemio Mojon, PhD",{"name":167,"role":31,"phone":24,"phoneExt":24,"email":24},"Jose R Fernandez, PhD",{"name":169,"role":31,"phone":24,"phoneExt":24,"email":24},"Maria J Fontao, PhD",{"facility":171,"status":41,"city":172,"state":62,"zip":173,"country":45,"countryCode":46,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"CS San Roque","Vilagarcía de Arousa","36600",{"type":48,"coordinates":175},[176,177],-8.76426,42.59631,{"lat":177,"lon":176},[180,184,186,188,190,192,194,196],{"name":181,"role":31,"phone":182,"phoneExt":24,"email":183},"Envira Sineiro, MD","34986507448","Elvira.Sineiro.Galinanes@sergas.es",{"name":185,"role":31,"phone":24,"phoneExt":24,"email":24},"Elvira Sineiro, MD",{"name":187,"role":31,"phone":24,"phoneExt":24,"email":24},"Margarita Alvariño",{"name":189,"role":31,"phone":24,"phoneExt":24,"email":24},"Luis M Fontenla",{"name":191,"role":31,"phone":24,"phoneExt":24,"email":24},"Margarita Fraga, MD",{"name":193,"role":31,"phone":24,"phoneExt":24,"email":24},"Barbara Llovo",{"name":195,"role":31,"phone":24,"phoneExt":24,"email":24},"Rita Martinez",{"name":197,"role":31,"phone":24,"phoneExt":24,"email":24},"Santiago Santidrian, MD",{"type":28,"investigatorFullName":199,"investigatorTitle":200,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ramon C. Hermida","Professor and Director, Bioengineering & Chronobiology Labs.","100320848","treatment-of-hypertension-during-sleep-100320848",false,"NCT03457168","Treatment of Hypertension During Sleep","A Prospective, Randomized, Open-label Clinical Trial on the Effects of Intensive Versus Conventional Control of Ambulatory-determined Asleep Systolic Blood Pressure Mean on Cardiovascular, Metabolic, and Renal Disease Risks","THADEUS","Inclusion Criteria:\n\n1. Men and women aged ≥18 years.\n2. All participants must: (i) have at randomization sleep-time hypertension according to the current ESH\u002FESC guidelines, i.e., asleep SBP mean ≥120 mmHg;1 (ii) adhere to a routine of daytime activity and nighttime sleep; and (iii) provide their written informed consent to participate into the study.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. History of drug\u002Falcohol abuse within the last two years.\n3. Night\u002Fshift-work employment.\n4. Previous history of a systemic autoimmune disease or AIDS.\n5. Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma\n6. CVD disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure, and grade III-IV retinopathy). Previous CVD events will not be exclusionary if full physical and work activities are maintained.\n7. Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug, or, at the discretion of the investigator, might place the subject at higher risk from his\u002Fher participation in the study, or are likely to prevent the subject from complying with the requirements of the study or completing the trial period.\n8. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years.\n9. Inability to communicate and comply with all study requirements.\n10. Intolerance to ABPM.","ALL","18 Years",{"count":212,"type":213},5320,"ESTIMATED","INTERVENTIONAL",[216],"NA","On the basis of new evidence on the relationship between achieved office blood pressure (BP) measurements (OBPM) and the risk of cardiovascular disease (CVD) morbidity and mortality documented in the SPRINT trial, the recent 2017 guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) have established lower values of 130\u002F80 mmHg for clinic systolic BP (SBP)\u002Fdiastolic BP (DBP) as new diagnostic thresholds for hypertension and therapeutic targets for treatment of all individuals aged ≥18 years regardless of age, sex, or concomitant complications including presence of diabetes, chronic kidney disease (CKD), or history of past CVD event. According to these guidelines, the new proposed ambulatory BP measurment (ABPM) thresholds for diagnosis of hypertension in adults are 130\u002F80 and 110\u002F65 mmHg for the awake and asleep SBP\u002FDBP means, respectively. However, the ACC\u002FAHA guidelines do not provide any scientific evidence documenting neither the equivalence between these ABPM thresholds and the 130\u002F80 mmHg cut-off values for OBPM nor the potential improved CVD event-free survival time of the proposed more intensive control of ambulatory BP.\n\nResults derived from observational prospective studies consistently document that therapeutic BP targets in hypertensive individuals, i.e., persons at increased CVD risk, should be established in terms of proper control of asleep BP. To date, no prospective randomized study has ever before evaluated which should be the adequate therapeutic ABPM target for most effective reduction of CVD risk. Accordingly, the Tratamiento de Hipertensión Arterial Durante el Sueño study (THADEUS, i.e., Treatment of Hypertension During Sleep) has been designed to prospectively evaluate if \"intensive control\" of asleep SBP mean proposed by the new ACC\u002FAHA guidelines (\\\u003C110 mmHg) in more effective than the so far its \"conventional control\" (\\\u003C120 mmHg) to reduce CVD morbidity and mortality in hypertensive individuals.",[219,220],"Hypertension","Hypertension, Systolic",[222,223,224,225,226,227,228],"Sleep-time hypertension","Ambulatory blood pressure monitoring","Hypertension chronotherapy","Asleep blood pressure","Cardiovascular risk","Type 2 diabetes","Chronic kidney disease","2024-12-03",{"date":231,"type":232},"2024-12-06","ACTUAL",{"date":234,"type":232},"2019-02-01",{"date":236,"type":213},"2032-12-31",{"name":5,"class":6},9]