Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT05780710

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 — OBPM_Meds2023  

Hypertension Clinical Trial

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 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05780710
Study type Interventional
Source Aktiia SA
Contact Pascale Vermare, Master
Phone +33666992877
Email pascale.vermare@aktiia.com
Status Recruiting
Phase N/A
Start date June 29, 2023
Completion date May 29, 2024
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A