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

Hypertension Clinical Trial

— OBPM_Meds2023  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780710
• Other study ID #: OBPM_Meds2023
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: May 29, 2024

Study information

• Verified date: August 2023
• Source: Aktiia SA
• Contact: Pascale Vermare, Master
• Phone: +33666992877
• Email: pascale.vermare[@]aktiia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicentric, randomised, comparative study Study duration: 13 weeks in total Population: 30 hypertensive (Stage 1 or 2) participants (25 participants minimum) Device Under Test (DUT): Aktiia device Reference: HBPM (Aktiia cuff) Periods of treatment: 2 weeks of treatment for each drug followed by a washout period of 2 weeks (3 drugs in total with a fixed dose, drug intake order is randomly assigned)

Description:

This study with N = 30 participants (25 participants minimum) over 4 visits has been designed to compare Aktiia device systolic and diastolic blood pressure measurements against HBPM reference measurements in participants taking 3 successive BP lowering drugs during 2 weeks per treatment. Periods of treatment are followed by 2 weeks of washout. Study participants are 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, naive of antihypertensive treatments at the inclusion in the study and during the conduct of the study apart from the study drugs.

Study participants are asked to:

Wear Aktiia bracelet continuously every day during 13 weeks in total, Initialize their bracelet with Aktiia cuff at different timepoints, Measure their blood pressure with an HBPM (Aktiia cuff) twice per day, Take their BP lowering medications during the treatment periods (2 weeks of treatment for each drug and 3 drugs in total), Complete 3 different surveys to give their feedback on Aktiia product use compared to HBPM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 29, 2024
• Est. primary completion date: May 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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 having medical interventions or taking treatments during the study that could have an impact on their BP

4. Subjects with tachycardia (heart rate at rest > 120bpm)

5. Subjects with atrial fibrillation

6. Cardio myopathy (FE<40%)

7. Severe valvular disease

8. Implanted devices such as a pacemaker or defibrillator

9. Subjects with diabetes

10. Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo)

11. Subjects with hyper-/hypothyroidism

12. Subjects with pheochromocytoma

13. Subjects with Raynaud's disease

14. Subjects with an arteriovenous fistula

15. Women in known pregnancy

16. Subjects with trembling and shivering

17. Subjects with lymphoedema

18. Low or elevated potassium level: threshold =3.5 mmol/L or =4.8 mmol/L

19. Presence of an intravascular device

20. Subjects with exfoliative skin diseases

21. Subjects with arm paralysis

22. Subjects with arm amputation

23. Subjects with upper arm circumference < 22cm or > 42cm

24. Subjects with wrist circumference > 23cm

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs
The device under test is Aktiia Optical Blood Pressure Monitoring (OBPM) device and the comparator is the Aktiia cuff. The 3 drug treatments are the following ones: Perindopril 5 mg (Angiotensin Converting Enzyme (ACE) inhibitors) Indapamide 1.5 mg (Diuretics) Amlodipine 5 mg (Calcium channel blockers)

Locations

Country	Name	City	State
Switzerland	HUG	Geneva
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Aktiia SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3)	Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)	Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)
Primary	Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 5 versus last 3 days of week 7)	Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)	Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7)
Primary	Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 9 versus last 3 days of week 11)	Statistics on the comparison of the changes in average daytime Blood Pressure values pre- and post-intervention between the two modalities (Aktiia device and HBPM)	Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)
Secondary	Participant's compliance	Number of measurements made each day by the Aktiia System	13 weeks
Secondary	Participant's compliance	Number of successful synchronizations with the Aktiia System	13 weeks
Secondary	Participant's perception	Compilation of answers to the surveys	13 weeks