Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508619
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-07
Brief Title:
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BPTreat
Brief Summary:
Rationale Wearables have the potential to monitor patients remotely The Corsano CardioWatch 287-2 is such a medical device that can monitor long-term blood pressure The device has been validated using clinical trials in hospitals but evaluation in the intended remote setting during treatment is lacking
Primary objective To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Study population A group untreated or treated for hypertension with uncontrolled BP and medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Study design Blood pressure will be measured by the investigative device and a reference device at pre-treatment and after 28 days The investigative device is the Corsano CardioWatch 287-2 which measures blood pressure through optical photoplethysmography PPG The reference method involves automatic blood pressure cuff measurements
Main study parametersendpoints Absolute systolic and diastolic blood pressure decrease after change of treatment measured by the Corsano Cardiowatch 287-2 after 28 days compared to automatic blood pressure cuff measurements
Primary objective To assess the ability to track blood pressure decrease measured by the Corsano CardioWatch 287-2 after a period of 28 days of antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Study population A group untreated or treated for hypertension with uncontrolled BP and medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Study design Blood pressure will be measured by the investigative device and a reference device at pre-treatment and after 28 days The investigative device is the Corsano CardioWatch 287-2 which measures blood pressure through optical photoplethysmography PPG The reference method involves automatic blood pressure cuff measurements
Main study parametersendpoints Absolute systolic and diastolic blood pressure decrease after change of treatment measured by the Corsano Cardiowatch 287-2 after 28 days compared to automatic blood pressure cuff measurements
Detailed Description:
Background and Introduction
Blood pressure BP is a cardiovascular risk factor that affects millions of people worldwide BP is a major determinant of stroke heart failure coronary artery disease and chronic kidney disease 1 Hypertension may be asymptomatic or episodic Accurate monitoring of BP is required to tailor medication to the patients specific needs to maintain blood pressure control 2 Therefore accurate and continuous monitoring of BP is crucial for optimal diagnosis treatment and prevention of cardiovascular events
However conventional methods for measuring BP have several limitations Most BP monitors use an occluding cuff that inflates periodically to obtain intermittent readings Cuff measurements may not reflect the true BP variations that occur throughout the day and night due to various factors such as physical activity stress level or sleep quality 3
Wearable devices are emerging as a promising alternative to conventional methods for measuring BP 4 5 6 They can measure BP continuously and non-invasively by using novel sensors and algorithms that do not require a cuff or electrodes Wearable devices can also enable remote monitoring and data transmission to healthcare providers or researchers However wearable devices need to be evaluated against standard methods in different clinical settings and patient populations
The Corsano CardioWatch 287-1 conforms with the European Medical Device Regulation CE-MDR and is a clinically validated vital signs monitoring bracelet It is able to continuously measure pulse rate 6 inter-beat intervals 6 breathing rate 7 sleep and activity The Corsano CardioWatch 287-2 an iteration on the 287-1 adds electrocardiogram ECG oxygen saturation SpO2 galvanic skin response GSR core body temperature and non-invasive blood pressure NIBP
The Corsano CardioWatch Corsano 287-2 has been submitted to laboratory tests against internationally recognized standards for the monitoring of pulse rate respiratory rate SpO2 GSR temperature and ECG Additionally the MULTI-VITAL study NL8023600022 has clinically validated Corsano 287-2 in a controlled intramural healthcare setting The Remote Cardiac Monitoring RECAMO study is underway to assess the free-living remote care setting long-term monitoring validity using a static test Clinical evaluation in a non-static remote care setting is still lacking however
Antihypertensive drugs reduce BP through blood volume reduction and vasodilatation which are very different physiological mechanisms This consequently changes the PPG waveform in distinct ways which constitutes a necessarily challenging test for cuffless devices The accuracy of the Corsano CardioWatch 287-2 during a change of antihypertensive treatment has not yet been evaluated However it is an important target for future use of the CardioWatch 287-2 Additionally it is a recommended research in the European Society of Hypertension ESH recommendations for the validation of cuffless blood pressure measuring devices 8
The current trial aims to clinically assess the Corsano CardioWatch 287-2 on blood pressure monitoring during antihypertensive treatment in a remote care setting
Objectives
The main objective is to assess the Corsano CardioWatch 287-2s ability to track blood pressure decrease over a period of 28 days after antihypertensive drug treatment initiation uptitration or change in antihypertensive drug
The assessment is done by comparing the blood pressure measurements of the Corsano CardioWatch 287-2 with those of an automatic cuff
Study Design
Patients who are untreated or treated for hypertension with uncontrolled BP and medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs will be approached for participation in the trial The ability of the CardioWatch 287-2 to track decreases in blood pressure will be assessed Blood pressure measured by the CardioWatch 287-2 at the beginning and end of the study period will be compared with the blood pressure measured by a reference device which is an automatic blood pressure cuff Blood pressure will be measured continuously by the Corsano CardioWatch 287-2 during 28 days These measurements are only meant for study purposes and not part of standard care
Blood pressure measurements with the Corsano cuff an automatic oscillometric blood pressure monitoring device will be used for initialization of the Corsano CardioWatch 287-2 on day 0 On day 1 the antihypertensive drug treatment initiation uptitration or change in antihypertensive drug will be started The automatic blood pressure cuff measurements at day 0 and 28 will be used to assess the CardioWatchs accuracy by comparing it to the closest available blood pressure measurement by the CardioWatch
The mean difference in blood pressure decrease between the Corsano CardioWatch 287-2 and reference automatic blood pressure cuff will be analyzed
Study population
The study will involve a patient group visiting the outpatient cardiology clinic at the Reinier de Graaf Gasthuis This group has an uncontrolled BP and therefore medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Sample size calculation
The participants will be included with the aim to assess the long-term variation in blood pressure during antihypertensive treatment Sample size calculation for the assessment of blood pressure monitoring is based on Association for the Advancement of Medical InstrumentationEuropean Society of HypertensionInternational Organization for Standardization AAMIESHISO consensus that at least 35 patients are required for the validation of a moderate accuracy device and recommends the following criteria to be met 8
Males 30 and females 30
Subjects with an added diuretic drug 35
Subjects with an added long-acting dihydropyridine calcium channel blocker 35
60 of the subjects need a reference systolic BP decrease 10 mmHg
60 of the subjects need a reference diastolic BP decrease 5 mmHg
30 of the subjects need a reference systolic BP decrease 10 mmHg
30 of the subjects need a reference diastolic BP decrease 5 mmHg Based on prior studies conducted by Corsano eg RECAMO Study the investigators experienced difficulty in obtaining a diverse study group in terms of inclusion requirements To meet these criteria the investigators will include at least 80 patients
Blood pressure BP is a cardiovascular risk factor that affects millions of people worldwide BP is a major determinant of stroke heart failure coronary artery disease and chronic kidney disease 1 Hypertension may be asymptomatic or episodic Accurate monitoring of BP is required to tailor medication to the patients specific needs to maintain blood pressure control 2 Therefore accurate and continuous monitoring of BP is crucial for optimal diagnosis treatment and prevention of cardiovascular events
However conventional methods for measuring BP have several limitations Most BP monitors use an occluding cuff that inflates periodically to obtain intermittent readings Cuff measurements may not reflect the true BP variations that occur throughout the day and night due to various factors such as physical activity stress level or sleep quality 3
Wearable devices are emerging as a promising alternative to conventional methods for measuring BP 4 5 6 They can measure BP continuously and non-invasively by using novel sensors and algorithms that do not require a cuff or electrodes Wearable devices can also enable remote monitoring and data transmission to healthcare providers or researchers However wearable devices need to be evaluated against standard methods in different clinical settings and patient populations
The Corsano CardioWatch 287-1 conforms with the European Medical Device Regulation CE-MDR and is a clinically validated vital signs monitoring bracelet It is able to continuously measure pulse rate 6 inter-beat intervals 6 breathing rate 7 sleep and activity The Corsano CardioWatch 287-2 an iteration on the 287-1 adds electrocardiogram ECG oxygen saturation SpO2 galvanic skin response GSR core body temperature and non-invasive blood pressure NIBP
The Corsano CardioWatch Corsano 287-2 has been submitted to laboratory tests against internationally recognized standards for the monitoring of pulse rate respiratory rate SpO2 GSR temperature and ECG Additionally the MULTI-VITAL study NL8023600022 has clinically validated Corsano 287-2 in a controlled intramural healthcare setting The Remote Cardiac Monitoring RECAMO study is underway to assess the free-living remote care setting long-term monitoring validity using a static test Clinical evaluation in a non-static remote care setting is still lacking however
Antihypertensive drugs reduce BP through blood volume reduction and vasodilatation which are very different physiological mechanisms This consequently changes the PPG waveform in distinct ways which constitutes a necessarily challenging test for cuffless devices The accuracy of the Corsano CardioWatch 287-2 during a change of antihypertensive treatment has not yet been evaluated However it is an important target for future use of the CardioWatch 287-2 Additionally it is a recommended research in the European Society of Hypertension ESH recommendations for the validation of cuffless blood pressure measuring devices 8
The current trial aims to clinically assess the Corsano CardioWatch 287-2 on blood pressure monitoring during antihypertensive treatment in a remote care setting
Objectives
The main objective is to assess the Corsano CardioWatch 287-2s ability to track blood pressure decrease over a period of 28 days after antihypertensive drug treatment initiation uptitration or change in antihypertensive drug
The assessment is done by comparing the blood pressure measurements of the Corsano CardioWatch 287-2 with those of an automatic cuff
Study Design
Patients who are untreated or treated for hypertension with uncontrolled BP and medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs will be approached for participation in the trial The ability of the CardioWatch 287-2 to track decreases in blood pressure will be assessed Blood pressure measured by the CardioWatch 287-2 at the beginning and end of the study period will be compared with the blood pressure measured by a reference device which is an automatic blood pressure cuff Blood pressure will be measured continuously by the Corsano CardioWatch 287-2 during 28 days These measurements are only meant for study purposes and not part of standard care
Blood pressure measurements with the Corsano cuff an automatic oscillometric blood pressure monitoring device will be used for initialization of the Corsano CardioWatch 287-2 on day 0 On day 1 the antihypertensive drug treatment initiation uptitration or change in antihypertensive drug will be started The automatic blood pressure cuff measurements at day 0 and 28 will be used to assess the CardioWatchs accuracy by comparing it to the closest available blood pressure measurement by the CardioWatch
The mean difference in blood pressure decrease between the Corsano CardioWatch 287-2 and reference automatic blood pressure cuff will be analyzed
Study population
The study will involve a patient group visiting the outpatient cardiology clinic at the Reinier de Graaf Gasthuis This group has an uncontrolled BP and therefore medical indication for antihypertensive drug treatment initiation uptitration or change in antihypertensive drugs
Sample size calculation
The participants will be included with the aim to assess the long-term variation in blood pressure during antihypertensive treatment Sample size calculation for the assessment of blood pressure monitoring is based on Association for the Advancement of Medical InstrumentationEuropean Society of HypertensionInternational Organization for Standardization AAMIESHISO consensus that at least 35 patients are required for the validation of a moderate accuracy device and recommends the following criteria to be met 8
Males 30 and females 30
Subjects with an added diuretic drug 35
Subjects with an added long-acting dihydropyridine calcium channel blocker 35
60 of the subjects need a reference systolic BP decrease 10 mmHg
60 of the subjects need a reference diastolic BP decrease 5 mmHg
30 of the subjects need a reference systolic BP decrease 10 mmHg
30 of the subjects need a reference diastolic BP decrease 5 mmHg Based on prior studies conducted by Corsano eg RECAMO Study the investigators experienced difficulty in obtaining a diverse study group in terms of inclusion requirements To meet these criteria the investigators will include at least 80 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None