HypertensionHP-HBMPNCT07273578

HOME BLOOD PRESSURE MONITORING IN PATIENTS WITH UNCONTROLLED HYPERTENSION: A RANDOMIZED CLINICAL TRIAL

A study testing Home Blood Pressure Monitoring in people with Hypertension, run by Universidade Federal do Ceara at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Home Blood Pressure Monitoring
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteBrazil
Study dates: 12 Dec 2022to 30 Sep 2023
Phase: Interventional
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Inclusion criteria: a) Patients diagnosed with hypertension, whether or not associated with DM, CAD or RI; b) Time since diagnosis greater than 6 months; c) BP > 140/90 mmHg obtained in triplicate during the initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study; d) Having been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report; e) Having mobility conditions to attend follow-up consultations at the health unit.

Exclusion Criteria: a) Pregnant women or women actively seeking to become pregnant; b) Have physical incapacity (represented by the presence of tetraplegia, tetraparesis, triplegia, triparesis, hemiplegia, hemiparesis, amputation or cerebral palsy), cognitive incapacity (represented by the presence of dementia, depression, delirium and mental illnesses, such as schizophrenia, oligophrenia and paraphrenia), and have undergone surgical procedures, accidents, amputation, oncological treatment that prevents self-monitoring of BP; c) Inability to maintain the monitor at home, represented by the participant's refusal to receive and/or keep the device; d) Acute cardiovascular event (myocardial infarction and stroke) in the last three months; e) Have a medical diagnosis of arrhythmia, as per the participant's self-report and confirmation in the medical record. f) Perform home BP measurement, represented by the participant's report. -

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal do Ceará
Fortaleza, Ceará/BRASIL

Other trials in Brazil

About this study

Official title: Home Blood Pressure Monitoring in Patients With Uncontrolled Hypertension: a Randomized Clinical Trial

This study aimed to test Home Blood Pressure Monitoring (HBPM) in reducing blood pressure (BP) levels in individuals with uncontrolled hypertension. Data collection was conducted in 5 stages: 1) recruitment; 2) inclusion in the study and collection of baseline data, including information on sociodemographic issues, anthropometric and clinical profile, and adherence to medication treatment; 3) randomization; 4) intervention; and 5) Reassessment of adherence to medication treatment. All participants will be monitored by the research team in three follow-up visits at the unit. The intervention consisted of HBPM being performed by participants in the IG, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month. Participants in the CG did not perform HBPM, but were also monitored by the research team in their follow-up visits. In these follow-up visits, for both groups, the researchers performed new BP measurements using the oscillometric method.

Read the detailed description

The outcome was the reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.

The Omron HEM-1100® automatic clinical monitor was used to perform oscillometric BP measurement in the unit.

The HEM 7122 automatic BP monitor was made available to IG participants for self-measurement of BP at home. The following were included:

Patients diagnosed with hypertension associated or not with DM, CAD or RI;
Time since diagnosis greater than 6 months;
BP > 140/90 mmHg obtained in triplicate during an initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study;
They had been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report;
They were able to move around and attend follow-up appointments at the health unit. The random allocation of participants into the two groups (G1 and CG) was performed proportionally (1:1) using Research Randomizer 1, which generated the sequence of entry by sets (set 01: G1, Set 02: CG). The numbers generated were previously recorded in sealed envelopes, which were opened in the presence of the participants immediately after collecting the variables at baseline and completing the data collection instrument. After randomization, the researcher informed the IG participant that he would undergo the intervention with HBPM during the follow-up period of three consecutive appointments scheduled by the unit. To this end, he would be loaned an automatic BP monitor provided by the researcher for the duration of the study and that it should be returned at the end. The CG participant was also informed by the researcher about the monitoring by the research team, which would include taking BP measurements using the oscillometric method during the period of three consecutive return appointments scheduled by the unit.

Conditions: Hypertension
Being tested: Home Blood Pressure Monitoring
Keywords: Hypertension, Blood Pressure Determination, UNCONTROLLED HYPERTENSION
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home Blood Pressure MonitoringProcedure or surgery
The intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.

Study groups in NCT07273578
Study group	Role	What they receive
Grupo intervenção (GI)	Active comparator	The intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month. Receives: Procedure: Home Blood Pressure Monitoring
Grupo controle (GC)	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction in average Systolic and Diastolic Blood Pressure values
Reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 202230 Sep 2023

First posted9 Dec 2025
Study start12 Dec 2022
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Model description: The intervention consisted of implementing HBPM to individuals with uncontrolled hypertension who were allocated to the IG, where they performed four measurements per day, two in the morning and two at night, before meals, for 5 consecutive days each month during follow-up, during three follow-up appointments at the unit. They also received a monthly telephone call to remind them to perform the measurements.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07273578
Sponsor's protocol ID: nº 5.769.427
Acronym: HP-HBMP
Status last verified: Nov 2025
First submitted: 27 Jan 2025
Last updated: 9 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: all collected IPD

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home Blood Pressure Monitoring in Patients With Uncontrolled Hypertension: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT07273578
Acronym / sponsor ID: HP-HBMP / nº 5.769.427
Conditions: Hypertension
Keywords: Hypertension, Blood Pressure Determination, UNCONTROLLED HYPERTENSION
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Universidade Federal do CearaUniversity, hospital or other
Collaborators: Coordination for the Improvement of Higher Education Personnel
Study start: 12 Dec 2022 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 9 Dec 2025 (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.

Detailed description

The Omron HEM-1100® automatic clinical monitor was used to perform oscillometric BP measurement in the unit.

The HEM 7122 automatic BP monitor was made available to IG participants for self-measurement of BP at home. The following were included:

Patients diagnosed with hypertension associated or not with DM, CAD or RI;
Time since diagnosis greater than 6 months;
BP > 140/90 mmHg obtained in triplicate during an initial clinical consultation conducted by the researchers, immediately after the invitation to participate in the study;
They had been following the same antihypertensive drug treatment for at least 4 weeks, according to the participant's self-report;
They were able to move around and attend follow-up appointments at the health unit. The random allocation of participants into the two groups (G1 and CG) was performed proportionally (1:1) using Research Randomizer 1, which generated the sequence of entry by sets (set 01: G1, Set 02: CG). The numbers generated were previously recorded in sealed envelopes, which were opened in the presence of the participants immediately after collecting the variables at baseline and completing the data collection instrument. After randomization, the researcher informed the IG participant that he would undergo the intervention with HBPM during the follow-up period of three consecutive appointments scheduled by the unit. To this end, he would be loaned an automatic BP monitor provided by the researcher for the duration of the study and that it should be returned at the end. The CG participant was also informed by the researcher about the monitoring by the research team, which would include taking BP measurements using the oscillometric method during the period of three consecutive return appointments scheduled by the unit.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: The intervention consisted of implementing HBPM to individuals with uncontrolled hypertension who were allocated to the IG, where they performed four measurements per day, two in the morning and two at night, before meals, for 5 consecutive days each month during follow-up, during three follow-up appointments at the unit. They also received a monthly telephone call to remind them to perform the measurements.

Arm	Type	Receives
Grupo intervenção (GI)	Active comparator	Procedure: Home Blood Pressure MonitoringThe intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.
Grupo controle (GC)	No intervention	–

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

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
Home Blood Pressure MonitoringThe intervention consisted of HBPM being performed by IG participants, who were loaned an automatic BP monitor to take measurements at home, for 5 consecutive days each month.	Procedure or surgery	Grupo intervenção (GI)

Primary outcome

Reduction in average Systolic and Diastolic Blood Pressure values
Time frame: 9 months
Reduction in mean SBP and DBP values over time within and between groups, consisting of a reduction with a significant difference between the baseline and the post-intervention period.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
Individual participant dataSharing planned: Yes. all collected IPD

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Home Blood Pressure Monitoring in people with Hypertension, run by Universidade Federal do Ceara at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in average Systolic and Diastolic Blood Pressure values (time frame: 9 months). 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 NCT07273578.

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 9 Dec 2025.