Blood PressureAMBP-waitingNCT06198855
Automated Measurement of Blood Pressure in Waiting Room (AMBP-waiting)
An observational study of Blood Pressure and Hypertension, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension, Blood Pressure Measurement
- What is being tested?
- QMon-20 device
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Indication for 24-h holter pressure study for hypertension diagnosis.
- Indication for 24-h holter pressure study for assess hypertension control
Who cannot join
- Any inability to perform 24-h ambulatory BP measurements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Automated Measurement of Blood Pressure in Waiting Appointment Versus 24-h Ambulatory Measurements
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.
Read the 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
- Being tested
- QMon-20 device
- Keywords
- Blood Pressure measurement., Automatic Blood Pressure office assessment.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMon-20 deviceDevice
Also called 24-h monitor BP
Automatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension Diagnosis | Subject need 24-h BP monitor for hypertension diagnosis Receives: Device: QMon-20 device | |
| hypertension control evaluation | Patients need 24-h BP monitor for assessment hypertension control Receives: Device: QMon-20 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- JUAN F SANCHEZ M-TORRERO, PhD, Principal investigator, Universidad Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198855
- Sponsor's protocol ID
- DTS19/00003
- Acronym
- AMBP-waiting
- Status last verified
- Dec 2023
- First submitted
- 27 Dec 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Recruitment in others hospital.
Publications
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.
PubMed 31196667Rico-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.
PubMed 34001760Sanchez 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.
PubMed 41085208
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Measurement of Blood Pressure in Waiting Appointment Versus 24-h Ambulatory Measurements
- ClinicalTrials.gov ID
- NCT06198855
- Acronym / sponsor ID
- AMBP-waiting / DTS19/00003
- Conditions
- Blood Pressure, Hypertension, Blood Pressure Measurement
- Keywords
- Blood Pressure measurement., Automatic Blood Pressure office assessment.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fundación para la Formación e Investigación de los Profesionales de la Salud de ExtremaduraUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension Diagnosis | – | Device: QMon-20 deviceSubject need 24-h BP monitor for hypertension diagnosis |
| hypertension control evaluation | – | Device: QMon-20 devicePatients need 24-h BP monitor for assessment hypertension control |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Indication for 24-h holter pressure study for hypertension diagnosis.
- Indication for 24-h holter pressure study for assess hypertension control
Key exclusion criteria (1 listed)
- Any inability to perform 24-h ambulatory BP measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMon-20 deviceAlso: 24-h monitor BPAutomatic Blood pressure measurement with QMon-20 device in the waiting room for 20 minutes every 5 minutes. | Device | Hypertension Diagnosis, hypertension control evaluation |
Primary outcome
concordance of systolic and diastolic BP mean between waiting room measurements and 24-h monitor mean.
Time frame: 6 MONTHS
mm Hg differences between measurements in the office with 24-h monitor
concordance of systolic and diastolic BP mean between waiting room measurements and 24-h diurnal monitor mean.
Time frame: 6 MONTHS
mm Hg differences between measurements in the office with 24-h monitor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 31196667Robles 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.
- Results publication: PubMed 34001760Rico-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.
- Derived from this study: PubMed 41085208Sanchez 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.
- Individual participant dataSharing planned: Yes. Recruitment in others hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUAN F SANCHEZ M-TORRERO, PhD principal investigator
Universidad Extremadura
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Hypertension, run by Fundación para la Formación e Investigación de los Profesionales de la Salud de Extremadura.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JUAN F SANCHEZ MUÑOZ-TORRERO, Ph D (0034656259939, juanf.sanchezm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concordance of systolic and diastolic BP mean between waiting room measurements and 24-h monitor mean. (time frame: 6 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198855, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.