Back to resultsMulticentric 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)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs
Sponsored by
About this trial
This is an interventional other trial for Hypertension focused on measuring Hypertension, Blood Pressure
Eligibility Criteria
Inclusion Criteria: Adult subjects aged 21 to 85 years old Subjects that can read and speak French Subjects that own a smart phone that uses either the iOS or Android operating system 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 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 Subjects agreeing to attend all 4 on-site visits and follow study procedures Subjects that have signed the informed consent form Exclusion Criteria: Subjects have contraindications to the study drugs Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg) Subjects having medical interventions or taking treatments during the study that could have an impact on their BP Subjects with tachycardia (heart rate at rest > 120bpm) Subjects with atrial fibrillation Cardio myopathy (FE<40%) Severe valvular disease Implanted devices such as a pacemaker or defibrillator Subjects with diabetes Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo) Subjects with hyper-/hypothyroidism Subjects with pheochromocytoma Subjects with Raynaud's disease Subjects with an arteriovenous fistula Women in known pregnancy Subjects with trembling and shivering Subjects with lymphoedema Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L Presence of an intravascular device Subjects with exfoliative skin diseases Subjects with arm paralysis Subjects with arm amputation Subjects with upper arm circumference < 22cm or > 42cm Subjects with wrist circumference > 23cm
Sites / Locations
- HUG
- CHUVRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Meds2023 Cohort
Arm Description
Study 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. In parallel, study 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).
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
Participant's compliance
Number of measurements made each day by the Aktiia System
Participant's compliance
Number of successful synchronizations with the Aktiia System
Participant's perception
Compilation of answers to the surveys
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05780710
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
May 29, 2024 (Anticipated)
Study Completion Date
May 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aktiia SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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)
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Blood Pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study 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.
In parallel, study 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. The order of drug intake is randomly assigned for every participant.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meds2023 Cohort
Arm Type
Other
Arm Description
Study 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.
In parallel, study 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).
Intervention Type
Other
Intervention Name(s)
Aktiia Optical Blood Pressure Monitoring (OBPM) device and antihypertensive drugs
Other Intervention Name(s)
Aktiia system, Aktiia device, Aktiia bracelet, Aktiia cuff
Intervention Description
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)
Primary Outcome Measure Information:
Title
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 1 versus last 3 days of week 3)
Description
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)
Time Frame
Last 3 days of the washout period (week 1), against the last 3 days of the treatment period (week 3)
Title
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 5 versus last 3 days of week 7)
Description
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)
Time Frame
Last 3 days of the washout period (week 5), against the last 3 days of the treatment period (week 7)
Title
Daytime Systolic and Diastolic Blood Pressure averages (last 3 days of week 9 versus last 3 days of week 11)
Description
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)
Time Frame
Last 3 days of the washout period (week 9), against the last 3 days of the treatment period (week 11)
Secondary Outcome Measure Information:
Title
Participant's compliance
Description
Number of measurements made each day by the Aktiia System
Time Frame
13 weeks
Title
Participant's compliance
Description
Number of successful synchronizations with the Aktiia System
Time Frame
13 weeks
Title
Participant's perception
Description
Compilation of answers to the surveys
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects aged 21 to 85 years old
Subjects that can read and speak French
Subjects that own a smart phone that uses either the iOS or Android operating system
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 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
Subjects agreeing to attend all 4 on-site visits and follow study procedures
Subjects that have signed the informed consent form
Exclusion Criteria:
Subjects have contraindications to the study drugs
Subjects with Hypertension Stage 3 (SBP/DBP >180/110 mmHg)
Subjects having medical interventions or taking treatments during the study that could have an impact on their BP
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Cardio myopathy (FE<40%)
Severe valvular disease
Implanted devices such as a pacemaker or defibrillator
Subjects with diabetes
Subjects with renal dysfunctions (eGFR < 45mL/min/1.73 m2 for patients between 21-85 yo)
Subjects with hyper-/hypothyroidism
Subjects with pheochromocytoma
Subjects with Raynaud's disease
Subjects with an arteriovenous fistula
Women in known pregnancy
Subjects with trembling and shivering
Subjects with lymphoedema
Low or elevated potassium level: threshold ≤3.5 mmol/L or ≥4.8 mmol/L
Presence of an intravascular device
Subjects with exfoliative skin diseases
Subjects with arm paralysis
Subjects with arm amputation
Subjects with upper arm circumference < 22cm or > 42cm
Subjects with wrist circumference > 23cm
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascale Vermare, Master
Phone
+33666992877
Email
pascale.vermare@aktiia.com
Facility Information:
Facility Name
HUG
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belén Ponte, MD Prof
Facility Name
CHUV
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grégoire Wuerzner, MD Prof
Phone
+41213141131
Email
gregoire.wuerzner@chuv.ch
12. IPD Sharing Statement
Learn more about this trial
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
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