💬In plain words
What the trial is, and whether it could suit you
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
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📋 Eligibility rules (as published)
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.
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