Automated Measurement of Blood Pressure in Waiting Room (AMBP-waiting)

NCT ID: NCT06198855

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-06-30

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 personnel(ABPM-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.

Therefore,availability 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.

Conditions

Blood Pressure; Hypertension; Blood Pressure Measurement

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Hypertension Diagnosis

Subject need 24-h BP monitor for hypertension diagnosis

QMon-20 device

Intervention Type: DEVICE

Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.

hypertension control evaluation

Patients need 24-h BP monitor for assessment hypertension control

QMon-20 device

Intervention Type: DEVICE

Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.

Interventions

QMon-20 device

Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.

Intervention Type: DEVICE

Other Intervention Names

24-h monitor BP

Eligibility Criteria

Inclusion Criteria

• Indication for 24-h holter pressure study for hypertension diagnosis.
• Indication for 24-h holter pressure study for assess hypertension control

Exclusion Criteria

• Any inability to perform 24-h ambulatory BP measurements.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JUAN F SANCHEZ M-TORRERO, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Extremadura

Central Contacts

JUAN F SANCHEZ MUÑOZ-TORRERO, Ph D

Role: CONTACT

juanf.sanchezm@gmail.com

0034656259939

JONHATAN GOMEZ RAJA, Dr

Role: CONTACT

jonathan.gomez@fundesalud.es

0034620962640

References

Robles NR, Sanchez Munoz-Torrero JF. Automated blood pressure measurement in consultation. Med Clin (Barc). 2020 Jan 24;154(2):59-60. doi: 10.1016/j.medcli.2019.04.009. Epub 2019 Jun 11. No abstract available. English, Spanish.

Reference Type: RESULT

PMID: 31196667 (View on PubMed)

Rico-Martin S, Sanchez-Bacaicoa M, Calderon-Garcia JF, Labrador-Gomez PJ, De Nicolas Jimenez JM, Villa-Rincon J, Robles NR, Guijarro C, Iammarino C, Rodilla-Salas E, Sanchez Munoz-Torrero JF. Validation of the QMon-20 oscillometric blood pressure monitor for professional office use in the general population according to the ANSI/ESH/ISO 81060-2:2018 protocol. Blood Press Monit. 2021 Oct 1;26(5):393-395. doi: 10.1097/MBP.0000000000000540.

Reference Type: RESULT

PMID: 34001760 (View on PubMed)

Sanchez Bacaicoa M, Rico S, Gullon A, Fernandez Pardo J, Villa J, Nadiejda E, Robles R, Del Aguila JM, Cunha P, Vassilenko V, Rodilla E, Sanchez Munoz-Torrero JF. Automated Office Blood Pressure Measurements in Waiting Room or Isolated Room for Diagnosis and Phenotyping of Hypertension. J Am Heart Assoc. 2025 Oct 14:e038011. doi: 10.1161/JAHA.124.038011. Online ahead of print.

Reference Type: DERIVED

PMID: 41085208 (View on PubMed)

Other Identifiers

DTS19/00003

Identifier Type: -

Identifier Source: org_study_id