Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198855
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-12-27
Brief Title:
Automated Measurement of Blood Pressure in Waiting Room AMBP-waiting
Sponsor:
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Organization:
Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
Study Overview
Official Title:
Automated Measurement of Blood Pressure in Waiting Appointment Versus 24-h Ambulatory Measurements
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMBP-waiting
Brief Summary:
The investigators will study 500 patients with any indication for 24-hours Ambulatory Blood Pressure Monitoring ABPM In this study will compare Blood Pressure measurements with an original automatic device every 5 minutes during 20 minutes while the subject waits room for appointment against ABPM results
Detailed Description:
The objective in the care of the hypertensive patient must be to establish a correct diagnosis and obtain a correct control of the BP with the ultimate aim of reducing cardiovascular morbidity and mortality Classically a degree of knowledge of 50 of the hypertensive population has been considered 50 of these received treatment and 50 of the latter were controlled which means a control of 25 of known hypertensive patients The causes that lead to this deficit control are varied Low degree of treatment completion therapeutic inertia - static therapeutic attitude to the poorly controlled patient - and the incorrect measurement of blood pressure values Therefore within the control measures to control hypertension an effort should be made to improve blood pressure measurement techniques Accurate knowledge of blood pressure BP figures is critical for diagnosis prognosis and therapeutic decision However despite the magnitude of the problem and the huge amount of clinical studies physicians continue to need an optimal technique that can be applied in daily practice Even in the main population-based studies such as NHANES they compared the control of BP with different measurement methods More recently the method applied in the SPRINT study has raised great controversy This technique consists in the measurement of automatic BP in office without the presence of health personnelABPM-office largely avoiding the white coat effect Their results have influenced the change in the diagnostic figures of hypertension and therapeutic objectives in the recommendations of the American and European guidelines
This new method was recommended by some scientific societies and in the future could become a reference technique for measuring BP in appointment A has been shown to obtain readings similar to those of 24h-ABPM and its clinical utility has been demonstrated in a large randomized clinical trial CAMBO This method was used in the SPRINT study and some scientific societies have proposed it for the diagnosis of hypertension and recommending it if we do not have 24h-ABPM or it is necessary to perform repeated assessments of BP The Canadian Society of Hypertension has officially recommended its use and the technique is regularly used by more than 50 of primary care physicians Despite the positive results both in US and Europe this technique has drawbacks that limit its generalization in real-life The setting of commercial devices are limited and their are compact table-top device that does not allow patient mobilization Finally examination should be performed with the patient alone in a quiet place and close to the consultation that is rarely available in many health systems
Thereforeavailability of an easy-to-use portable BP device which allows BP measured automatically while the patient waits in the medical consultation room could avoid the white coat effect by providing a accurate BP measurement and avoid a large number of studies
This new method was recommended by some scientific societies and in the future could become a reference technique for measuring BP in appointment A has been shown to obtain readings similar to those of 24h-ABPM and its clinical utility has been demonstrated in a large randomized clinical trial CAMBO This method was used in the SPRINT study and some scientific societies have proposed it for the diagnosis of hypertension and recommending it if we do not have 24h-ABPM or it is necessary to perform repeated assessments of BP The Canadian Society of Hypertension has officially recommended its use and the technique is regularly used by more than 50 of primary care physicians Despite the positive results both in US and Europe this technique has drawbacks that limit its generalization in real-life The setting of commercial devices are limited and their are compact table-top device that does not allow patient mobilization Finally examination should be performed with the patient alone in a quiet place and close to the consultation that is rarely available in many health systems
Thereforeavailability of an easy-to-use portable BP device which allows BP measured automatically while the patient waits in the medical consultation room could avoid the white coat effect by providing a accurate BP measurement and avoid a large number of studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None