Blood PressureNCT04027777
Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
A study testing Aktiia.product-P0 in people with Blood Pressure, run by Aktiia SA at 1 site in Switzerland.
Trial summary
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Aktiia.product-P0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Aug 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects (aged between 21 and 65 years old)
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects that have signed the informed consent form
- Adult subjects (aged between 21 and 65 years old)
- Subjects fluent in written and spoken French
Show all 12Show fewer
- Subjects agreeing to attend the totality of 4 visits
- Subjects that have signed the informed consent form
- Adult subjects (aged between 65 and 85 years old)
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects that have signed the informed consent form
Who cannot join
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with hyper-/hypothyroidism
- Subjects with pheochromocytoma
Show all 170Show fewer
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
- Subjects with lymphoedema (limitation due to participant discomfort)
- ARM2
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
- Subjects with lymphoedema (limitation due to participant discomfort)
- ARM3
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 22 cm (limitation due Aktiia.bracelet-P0 size)
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
- Subjects with lymphoedema (limitation due to participant discomfort)
- ARM 4
- The study arm will include:
- Adult subjects aged between 21 and 85 years old
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects residing within 100 km of the CHUV site
- Subjects able to pedal with an ergocycle
- Subjects that have signed the informed consent form
- The study will exclude:
- Subjects undergoing dialysis treatment
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with untreated hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 23 cm
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
- ARM 5
- The study arm will include:
- Adult subjects aged between 21 and 85 years old
- Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects residing within 100 km of the CHUV site
- Subjects able to pedal with an ergocycle
- Subjects that have signed the informed consent form
- The study will exclude:
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with untreated hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 23 cm
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
- ARM 6
- The study arm will include:
- Subjects who are adult females aged 21 years or older
- Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist
- Subjects not requiring hospitalization
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects residing within 100 km of the CHUV site.
- Subjects that have signed the informed consent form
- The study will exclude:
- Subjects with tachycardia (heart rate at rest > 120bpm
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with untreated hyper/hypotyroidism not related to pregnancy changes
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Subjects with an arteriovenous fistula
- Subjects with arm amputations
- Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 23 cm
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema
- ARM 7
- The study arm will include:
- Subjects who are adult females aged 21 years or older
- Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects residing within 100 km of the CHUV site.
- Subjects that have signed the informed consent form
- The study will exclude:
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with untreated hyper-/hypothyroidism
- Subjects with pheochromocytoma
- Subjects with Raynaud's disease
- Subjects with trembling and shivering
- Subjects with interarm systolic difference > 15 mmHg
- Subjects with interarm diastolic difference > 10 mmHg
- Subjects with arm paralysis
- Women in known pregnancy
- Subjects with an arteriovenous fistula
- Subjects with arm amputations Subjects with the upper arm circumference > 64 cm
- Subjects with the wrist circumference > 23 cm
- Subjects with the central phalanx of the middle finger circumference > 71 mm or < 43 mm
- Subjects with the exfoliative skin diseases
- Subjects with lymphoedema.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Lausanne Hospitals
Lausanne, 1011
Grégoire Wuerzner, MD, +41213141131, gregoire.wuerzner@chuv.ch
About this study
Official title: Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks
Read the detailed description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population is not diagnosed, and half of the treated population is not at the defined target of BP. Widespread use of out of office BP measurement is one of the proposed strategies to fight against hypertension worldwide.
The current Ambulatory Blood Pressure Monitoring or Home Blood Pressure Monitoring are performed with a cuff placed around the arm. This 110-year-old technology is not only uncomfortable for the patient but can also result in a number of overestimated readings due to the stress induced while inflating the cuff.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor determining over a series of cardiac cycles the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist. The optical sensors integrated within the device exploit the principle of reflection photoplethysmography (PPG) to capture the user's skin pulsatility (change of arterial diameter occurring at each heartbeat). Aktiia OBPM algorithms are further applied to the recorded PPG signal to determine user's blood pressure and heart rate.
Because the measurement relies on optical sensors, and not on pneumatic cuffs, Aktiia OBPM device provides an increased overall comfort to the patient throughout the monitoring, does not induce sleep arousal during the night measurements and decreases the false positive readings induced by the stress associated with the cuff inflation. Aktiia OBPM device is intended to be used in the long term, as compared to one-day or one-week use of Ambulatory Blood Pressure Monitors.
This study over several visits has been designed to assess both the accuracy and the stability of the Aktiia OBPM. The automaticity of the measurement when performed in different body positions and upon aerobic exercise was also evaluated.
By demonstrating both the accuracy and the stability of the measurements that can be performed in different body positions with a comfortable and miniature Aktiia OBPM device, Aktiia SA aims to make one step further in facilitating blood pressure measurement and monitoring in the out-of-clinic scenarios and integrating blood pressure monitoring into user's daily life. The diagnosis and treatment of hypertension in ambulatory settings is expected to largely benefit from these advancements
- Conditions
- Blood Pressure
- Being tested
- Aktiia.product-P0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia.product-P0Device
The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| Aktiia.product-P0 | Experimental | Main study arm including 105 subjects Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 Diabetics | Experimental | Second study arm including 40 diabetic patients Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 Aged | Experimental | Thirs study arm including 40 patients aged 65+ Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 and subjects with Chronic Kidney disease | Experimental | Additional study arm including 40 subjects with chronic kidney disease (ARM 4) Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 and subjects with Heart Failure | Experimental | Additional study arm including 40 subjects with Heart Failure (ARM 5) Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 and Pregnant subjects | Experimental | Additional study arm including 50 pregnant subjects (ARM 6) Receives: Device: Aktiia.product-P0 |
| Aktiia.product-P0 and subjects in Post partum | Experimental | Additional study arm including 40 subjects in post partum (ARM 7) Receives: Device: Aktiia.product-P0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure absolute Mean Error
The absolute value of the mean of the differences between Reference and Aktiia.product-P0 blood pressure determinations
Measured: Up to four weeks
Blood Pressure standard Deviation of the Error
The standard deviation of the differences between Reference and Aktiia.product-P0 determinations
Measured: Up to four weeks
Secondary outcomes (1)
Heart Rate root-mean-square error
The root-mean-square difference between the Aktiia.product-P0 heart rate determinations and the Reference method
Measured: Up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start6 Aug 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Gregoire Wuerzner, MD, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027777
- Sponsor's protocol ID
- OBPM_Ambulatory2019
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2019
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Theiler K, Sola J, Damianaki A, Pfister A, Almeida TP, Alexandre J, Vermare P, Wuerzner G. Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions. Blood Press. 2023 Dec;32(1):2281320. doi: 10.1080/08037051.2023.2281320. Epub 2023 Nov 16.
PubMed 37971487
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
- ClinicalTrials.gov ID
- NCT04027777
- Acronym / sponsor ID
- OBPM_Ambulatory2019
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Collaborators
- University of Lausanne Hospitals
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks
Detailed description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population is not diagnosed, and half of the treated population is not at the defined target of BP. Widespread use of out of office BP measurement is one of the proposed strategies to fight against hypertension worldwide.
The current Ambulatory Blood Pressure Monitoring or Home Blood Pressure Monitoring are performed with a cuff placed around the arm. This 110-year-old technology is not only uncomfortable for the patient but can also result in a number of overestimated readings due to the stress induced while inflating the cuff.
Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor determining over a series of cardiac cycles the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist. The optical sensors integrated within the device exploit the principle of reflection photoplethysmography (PPG) to capture the user's skin pulsatility (change of arterial diameter occurring at each heartbeat). Aktiia OBPM algorithms are further applied to the recorded PPG signal to determine user's blood pressure and heart rate.
Because the measurement relies on optical sensors, and not on pneumatic cuffs, Aktiia OBPM device provides an increased overall comfort to the patient throughout the monitoring, does not induce sleep arousal during the night measurements and decreases the false positive readings induced by the stress associated with the cuff inflation. Aktiia OBPM device is intended to be used in the long term, as compared to one-day or one-week use of Ambulatory Blood Pressure Monitors.
This study over several visits has been designed to assess both the accuracy and the stability of the Aktiia OBPM. The automaticity of the measurement when performed in different body positions and upon aerobic exercise was also evaluated.
By demonstrating both the accuracy and the stability of the measurements that can be performed in different body positions with a comfortable and miniature Aktiia OBPM device, Aktiia SA aims to make one step further in facilitating blood pressure measurement and monitoring in the out-of-clinic scenarios and integrating blood pressure monitoring into user's daily life. The diagnosis and treatment of hypertension in ambulatory settings is expected to largely benefit from these advancements
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Aktiia.product-P0 | Experimental | Device: Aktiia.product-P0Main study arm including 105 subjects |
| Aktiia.product-P0 Diabetics | Experimental | Device: Aktiia.product-P0Second study arm including 40 diabetic patients |
| Aktiia.product-P0 Aged | Experimental | Device: Aktiia.product-P0Thirs study arm including 40 patients aged 65+ |
| Aktiia.product-P0 and subjects with Chronic Kidney disease | Experimental | Device: Aktiia.product-P0Additional study arm including 40 subjects with chronic kidney disease (ARM 4) |
| Aktiia.product-P0 and subjects with Heart Failure | Experimental | Device: Aktiia.product-P0Additional study arm including 40 subjects with Heart Failure (ARM 5) |
| Aktiia.product-P0 and Pregnant subjects | Experimental | Device: Aktiia.product-P0Additional study arm including 50 pregnant subjects (ARM 6) |
| Aktiia.product-P0 and subjects in Post partum | Experimental | Device: Aktiia.product-P0Additional study arm including 40 subjects in post partum (ARM 7) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult subjects (aged between 21 and 65 years old)
- Subjects fluent in written and spoken French
- Subjects agreeing to attend the totality of 4 visits
- Subjects that have signed the informed consent form
- Adult subjects (aged between 21 and 65 years old)
Key exclusion criteria (170 listed)
- Subjects with tachycardia (heart rate at rest > 120bpm)
- Subjects with atrial fibrillation
- Subjects with diabetes
- Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)
- Subjects with hyper-/hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aktiia.product-P0The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously. | Device | Aktiia.product-P0, Aktiia.product-P0 Aged, Aktiia.product-P0 Diabetics, Aktiia.product-P0 and Pregnant subjects, Aktiia.product-P0 and subjects in Post partum, Aktiia.product-P0 and subjects with Chronic Kidney disease, Aktiia.product-P0 and subjects with Heart Failure |
Primary outcome
Blood Pressure absolute Mean Error
Time frame: Up to four weeks
The absolute value of the mean of the differences between Reference and Aktiia.product-P0 blood pressure determinations
Blood Pressure standard Deviation of the Error
Time frame: Up to four weeks
The standard deviation of the differences between Reference and Aktiia.product-P0 determinations
1 secondary outcome
Heart Rate root-mean-square error
Time frame: Up to four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 37971487Theiler K, Sola J, Damianaki A, Pfister A, Almeida TP, Alexandre J, Vermare P, Wuerzner G. Performance of the Aktiia optical blood pressure measurement device in the elderly: a comparison with double blinded auscultation in different body positions. Blood Press. 2023 Dec;32(1):2281320. doi: 10.1080/08037051.2023.2281320. Epub 2023 Nov 16.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregoire Wuerzner, MD principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia.product-P0 in people with Blood Pressure, run by Aktiia SA at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 170 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Sola, PhD (+41797689800, josep@aktiia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure absolute Mean Error (time frame: Up to four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.