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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. Device 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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adult subjects aged 21 to 85 years old 2. Subjects that can read and speak French 3. Subjects that own a smart phone that uses either the iOS or Android operating system 4. 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, 5. 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 6. Subjects agreeing to attend all 4 on-site visits and follow study procedures 7. Subjects that have signed the willing to sign a consent form form Who Should NOT Join This Trial: 1. Subjects have contraindications to the study drugs 2. Subjects with Hypertension Stage 3 (SBP/DBP \>180/110 mmHg) 3. 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) 4. Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11 a.m. and 4 to 9 p.m.). 5. Subjects having medical interventions or taking treatments during the study that could have an impact on their BP 6. For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and/ or, albumin/creatinine ratio in urine ≥3.5 mg/mmol) 7. Subjects with tachycardia (heart rate at rest \> 120bpm) 8. Subjects with atrial fibrillation 9. Cardio myopathy (FE\<40%) 10. Severe valvular disease 11. Implanted devices such as a pacemaker or defibrillator 12. Subjects with diabetes 13. Subjects with renal dysfunctions (eGFR \< 45mL/min/1.73 m2 for patients between 21-85 yo) 14. Subjects with hyper-/hypothyroidism 15. Subjects with pheochromocytoma 16. Subjects with Raynaud's disease 17. Subjects with an arteriovenous fistula 18. Women in known pregnancy ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adult subjects aged 21 to 85 years old 2. Subjects that can read and speak French 3. Subjects that own a smart phone that uses either the iOS or Android operating system 4. 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, 5. 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 6. Subjects agreeing to attend all 4 on-site visits and follow study procedures 7. Subjects that have signed the informed consent form Exclusion Criteria: 1. Subjects have contraindications to the study drugs 2. Subjects with Hypertension Stage 3 (SBP/DBP \>180/110 mmHg) 3. 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) 4. Subjects who are likely to be unable to perform the HBPM required for the study within the designated time frame (7 to 11 a.m. and 4 to 9 p.m.). 5. Subjects having medical interventions or taking treatments during the study that could have an impact on their BP 6. For GROUPS 1 and 2 only: Subjects with target organ damage (left ventricular hypertrophy observed on ECG, and/ or, albumin/creatinine ratio in urine ≥3.5 mg/mmol) 7. Subjects with tachycardia (heart rate at rest \> 120bpm) 8. Subjects with atrial fibrillation 9. Cardio myopathy (FE\<40%) 10. Severe valvular disease 11. Implanted devices such as a pacemaker or defibrillator 12. Subjects with diabetes 13. Subjects with renal dysfunctions (eGFR \< 45mL/min/1.73 m2 for patients between 21-85 yo) 14. Subjects with hyper-/hypothyroidism 15. Subjects with pheochromocytoma 16. Subjects with Raynaud's disease 17. Subjects with an arteriovenous fistula 18. Women in known pregnancy 19. Subjects with trembling and shivering 20. Subjects with lymphoedema 21. Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L 22. Presence of an intravascular device 23. Subjects with exfoliative skin diseases 24. Subjects with arm paralysis 25. Subjects with arm amputation 26. Subjects with upper arm circumference \< 22cm or \> 42cm 27. Subjects with wrist circumference \> 23cm 28. Subjects with non-standard circadian rhythm, including shift workers and night workers 29. Subjects who have received a mastectomy.

Treatments Being Tested

OTHER

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. For study GROUP 1: Study drugs are: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * 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.

OTHER

Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs (monotherapy)

Study drugs: * Perindopril MEPHA (Angiotensin Converting Enzyme (ACE) inhibitors). * Indapamide MEPHA (Diuretics). * 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.

OTHER

Aktiia Optical Blood Pressure Monitoring (OBPM) device and individualized antihypertensive treatment

For study GROUP 3: Subjects will be prescribed an individualized new antihypertensive treatment at their consultation with the Investigator at Visit 1.

Locations (3)

HUG
Geneva, Canton of Geneva, Switzerland
CHVR
Sion, Valais, Switzerland
CHUV
Lausanne, Switzerland