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

NCT06198855 | Unknown

• 1 other identifier: DTS19/00003
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure; Hypertension; Blood Pressure Measurement

Keywords

Blood Pressure measurement.; Automatic Blood Pressure office assessment.

Outcome Measures

Primary Outcomes (2)

• concordance of systolic and diastolic BP mean between waiting room measurements and 24-h monitor mean.

  mm Hg differences between measurements in the office with 24-h monitor

  6 MONTHS

• concordance of systolic and diastolic BP mean between waiting room measurements and 24-h diurnal monitor mean.

  mm Hg differences between measurements in the office with 24-h monitor

  6 MONTHS

Study Arms (2)

Hypertension Diagnosis

Subject need 24-h BP monitor for hypertension diagnosis

Device: QMon-20 device

hypertension control evaluation

Patients need 24-h BP monitor for assessment hypertension control

Device: QMon-20 device

Interventions

QMon-20 device DEVICE

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

Also known as: 24-h monitor BP

Hypertension Diagnosis; hypertension control evaluation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Group 1: Patients with clinical indication to perform 24-h BP measurement study due to hypertension diagnostic Group 2: Patients with clinical indication to perform 24-h BP measurement study due to hypertension control

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura: lead
• Instituto de Salud Carlos III: collaborator

Related Publications (3)

• 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.

  PMID: 31196667 RESULT

• 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.

  PMID: 34001760 RESULT

• 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 21;14(20):e038011. doi: 10.1161/JAHA.124.038011. Epub 2025 Oct 14.

  PMID: 41085208 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• JUAN F SANCHEZ M-TORRERO, PhD

  Universidad Extremadura

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUAN F SANCHEZ MUÑOZ-TORRERO, Ph D

CONTACT

0034656259939; juanf.sanchezm@gmail.com

JONHATAN GOMEZ RAJA, Dr

CONTACT

0034620962640; jonathan.gomez@fundesalud.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 10, 2024
• Study Start: March 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months