NCT04027777 Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
| NCT ID | NCT04027777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aktiia SA |
| Condition | Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 355 participants |
| Start Date | 2019-08-06 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 355 participants in total. It began in 2019-08-06 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
ARM1 Inclusion Criteria: * 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 Exclusion Criteria: * 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) ARM2 Inclusion Criteria: * 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 Exclusion Criteria: * 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 Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Gregoire Wuerzner, MD
PRINCIPAL INVESTIGATOR
CHUV
Frequently Asked Questions
Who can join the NCT04027777 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04027777 currently recruiting?
Yes, NCT04027777 is actively recruiting participants. Contact the research team at josep@aktiia.com for enrollment information.
Where is the NCT04027777 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT04027777 clinical trial?
NCT04027777 is sponsored by Aktiia SA. The principal investigator is Gregoire Wuerzner, MD at CHUV. The trial plans to enroll 355 participants.