Evaluating a new blood pressure monitoring device in hypertensive patients
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
This study is testing a new blood pressure monitoring device to see if it works better than regular home monitoring for people with high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 3 sites (Geneva, Canton of Geneva and 2 other locations) |
| Trial ID | NCT05780710 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to compare the effectiveness of the Aktiia Optical Blood Pressure Monitoring (OBPM) device against standard home blood pressure monitoring (HBPM) in patients with hypertension. Participants will be divided into three groups based on their treatment status and blood pressure control, with each group undergoing a series of blood pressure measurements while taking different antihypertensive medications. The study will last between 4 to 19 weeks, depending on the group, and will involve continuous monitoring with the Aktiia device. The goal is to assess the accuracy and reliability of the Aktiia device in managing blood pressure in hypertensive patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 85 with Stage 1 or Stage 2 hypertension who are either naive to antihypertensive treatments or currently on monotherapy.
Not a fit: Patients with Stage 3 hypertension or those with contraindications to the study drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management for hypertensive patients through more accurate monitoring.
How similar studies have performed: Other studies have shown promise in using innovative blood pressure monitoring technologies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Geneva, Canton of Geneva and 2 other locations
- Hug — Geneva, Canton of Geneva, Switzerland (Terminated)
- Chvr — Sion, Valais, Switzerland (Withdrawn)
- Chuv — Lausanne, Switzerland (Recruiting)
Study contacts
- Study coordinator: Cléo Moulin, Master
- Email: cleo.moulin@aktiia.com
- Phone: +41798336172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.