[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499242":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":41,"centralContacts":42,"locations":52,"responsibleParty":93,"collaborators":41,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":41,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":80,"whyStopped":41,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Aktiia SA","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Meds2023 GROUP 1","OTHER","GROUP 1 participants are asked to wear the Aktiia bracelet continuously every day for 13 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.\n\nIn parallel, GROUP 1 participants are asked to take 3 successive Blood Pressure lowering drugs during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment).",[13],"Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)",{"label":15,"type":10,"description":16,"interventionNames":17},"Meds2023 GROUP 2","GROUP 2 participants are asked to wear the Aktiia bracelet continuously every day for 19 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.\n\nIn parallel, GROUP 2 participants are asked to stop their previous antihypertensive monotherapy for the first 2 weeks of the study participation and then take 3 successive blood pressure-lowering medications during 2 weeks per treatment. Treatment periods are followed by 2 weeks of washout (no treatment). Finally, they resume their initial monotherapy intake for a period of 4 weeks.",[18],"Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)",{"label":20,"type":10,"description":21,"interventionNames":22},"Meds2023 GROUP 3","GROUP 3 participants are asked to wear the Aktiia bracelet continuously every day for 4 weeks in total and initialize their Aktiia bracelet with the Aktiia cuff at different timepoints.\n\nIn parallel, GROUP 3 participants are asked to take their initial antihypertensive medication that doesn't allow them to have controlled blood pressure for 1 week. For the following 3 weeks of the study participation, GROUP 3 participants are asked to take an individualized antihypertensive therapy assigned by the investigator.",[23],"Other: Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment",[25,31,36],{"type":10,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy and bitherapy)","The device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff.\n\nFor study GROUP 1:\n\nStudy drugs are:\n\n* Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors).\n* Indapamide MEPHA (Diuretics).\n* Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 1 will receive one of the following for each treatment period: monotherapy with Indapamide, bitherapy with Indapamide plus Perindopril, or bitherapy with Perindopril plus Amlodipine.",[9],[30],"Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff",{"type":10,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)","Study drugs:\n\n* Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors).\n* Indapamide MEPHA (Diuretics).\n* Amlodipine MEPHA (Calcium channel blockers). In each study treatment period, subjects in GROUP 2 will receive one of the following monotherapies: Perindopril , Indapamide, or Amlodipine.",[15],[30],{"type":10,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment","For study GROUP 3:\n\nSubjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1.",[20],[30],null,[43,48],{"name":44,"role":45,"phone":46,"phoneExt":41,"email":47},"Cléo Moulin, Master","CONTACT","+41798336172","cleo.moulin@aktiia.com",{"name":49,"role":45,"phone":41,"phoneExt":50,"email":51},"Pascale Vermare, Master","+33666992877","pascale.vermare@aktiia.com",[53,67,78],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":41},"HUG","TERMINATED","Geneva","Canton of Geneva","1205","Switzerland","CH",{"type":62,"coordinates":63},"Point",[64,65],6.14569,46.20222,{"lat":65,"lon":64},{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":59,"countryCode":60,"cosmosGeoPoint":73,"geoPoint":77,"contacts":41},"CHVR","WITHDRAWN","Sion","Valais","1951",{"type":62,"coordinates":74},[75,76],7.35559,46.22739,{"lat":76,"lon":75},{"facility":79,"status":80,"city":81,"state":41,"zip":82,"country":59,"countryCode":60,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"CHUV","RECRUITING","Lausanne","1011",{"type":62,"coordinates":84},[85,86],6.63282,46.516,{"lat":86,"lon":85},[89],{"name":90,"role":45,"phone":91,"phoneExt":41,"email":92},"Grégoire Wuerzner, MD Prof","+41213141131","gregoire.wuerzner@chuv.ch",{"type":94,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100499242","obpmmeds2023-multicentric-prospective-clinical-study-to-evaluate-the-aktiia-optical-blood-pressure-monitoring-obpm-device-compared-to-standard-home-blood-pressure-monitoring-hbpm-in-hypertensive-patients-when-blood-pressure-lowering-medications-intake-100499242",false,"NCT05780710","OBPM_Meds2023: Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake","Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake","OBPM_Meds2023","Inclusion Criteria:\n\n1. Adult subjects aged 21 to 85 years old\n2. Subjects that can read and speak French\n3. Subjects that own a smart phone that uses either the iOS or Android operating system\n4. Hypertensive Stage 1 (SBP 140-159 mmHg or DBP 90-99 mmHg) or Hypertensive Stage 2 (SBP 160-179 mmHg or DBP 100-109 mmHg) or for subjects aged \\> 65yo SBP ≥160 mmHg,\n5. Naive of antihypertensive drugs at the inclusion in the study (no antihypertensive drugs taken in the last 3 months before Visit 1) and during the conduct of the study apart from the study drugs\n6. Subjects agreeing to attend all 4 on-site visits and follow study procedures\n7. Subjects that have signed the informed consent form\n\nExclusion Criteria:\n\n1. Subjects have contraindications to the study drugs\n2. Subjects with Hypertension Stage 3 (SBP\u002FDBP \\>180\u002F110 mmHg)\n3. Subjects with orthostatic hypotension (a 20 mmHg decrease in systolic BP, or 10 mmHg decrease in diastolic BP when measured in the standing position after a 1-minute waiting period)\n4. Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11\n\n   a.m. and 4 to 9 p.m.).\n5. Subjects having medical interventions or taking treatments during the study that could have an impact on their BP\n6. For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and\u002F or, albumin\u002Fcreatinine ratio in urine ≥3.5 mg\u002Fmmol)\n7. Subjects with tachycardia (heart rate at rest \\> 120bpm)\n8. Subjects with atrial fibrillation\n9. Cardio myopathy (FE\\\u003C40%)\n10. Severe valvular disease\n11. Implanted devices such as a pacemaker or defibrillator\n12. Subjects with diabetes\n13. Subjects with renal dysfunctions (eGFR \\\u003C 45mL\u002Fmin\u002F1.73 m2 for patients between 21-85 yo)\n14. Subjects with hyper-\u002Fhypothyroidism\n15. Subjects with pheochromocytoma\n16. Subjects with Raynaud's disease\n17. Subjects with an arteriovenous fistula\n18. Women in known pregnancy\n19. Subjects with trembling and shivering\n20. Subjects with lymphoedema\n21. Low or elevated potassium level: threshold ≤3.5 mmol\u002FL or ≥4.8 mmol\u002FL\n22. Presence of an intravascular device\n23. Subjects with exfoliative skin diseases\n24. Subjects with arm paralysis\n25. Subjects with arm amputation\n26. Subjects with upper arm circumference \\\u003C 22cm or \\> 42cm\n27. Subjects with wrist circumference \\> 23cm\n28. Subjects with non-standard circadian rhythm, including shift workers and night workers\n29. Subjects who have received a mastectomy.","ALL","21 Years","85 Years",{"count":107,"type":108},35,"ESTIMATED","INTERVENTIONAL",[111],"NA","Study design: Prospective, multicentric, randomized, comparative study Study duration: between 4 and 19 weeks depending on the study group. Population: minimum 35 hypertensives (stage 1 or stage 2) participants divided into 3 groups depending on hypertension criteria. GROUP 1 = untreated hypertensives, stage 1 or stage 2; GROUP 2 = hypertensives, stage 1, who are taking antihypertensive monotherapy; GROUP 3 = hypertensives, stage 1 or stage 2, who are taking antihypertensive treatment that doesn't allow them to have controlled blood pressure.\n\nDevice Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: For GROUPS 1 and 2, 2 weeks of treatment for each antihypertensive medication followed by a washout period of 2 weeks (3 antihypertensive medications in total with a fixed dose; medication intake order is randomly assigned). For GROUP 3, an individualized new antihypertensive medication will be prescribed during the consultation with the investigator that will be administered for 3 weeks.",[114],"Hypertension",[114,116],"Blood Pressure","2026-02-04",{"date":119,"type":120},"2026-02-05","ACTUAL",{"date":122,"type":120},"2023-06-29",{"date":124,"type":108},"2026-12-31",{"name":5,"class":6},3]