Ambulatory Blood Pressure MonitoringCABER-NETNCT05781256
Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life
An observational study of Ambulatory Blood Pressure Monitoring and Home Blood Pressure Monitoring, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Blood Pressure Monitoring, Home Blood Pressure Monitoring, Blood Pressure Determination
- How many people
- 173 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 27 Apr 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: * >18 years old * arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment * antihypertensive treatment stable over 2 weeks preceding enrolment * written informed consent Exclusion Criteria: * atrial fibrillation/flutter of frequent ectopic beats * pregnancy and lactation * terminal malignant disease, life expectancy <6 months * limb amputation * dementia
Who may be able to join
- >18 years old
- arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment
- antihypertensive treatment stable over 2 weeks preceding enrolment
- written informed consent
Who cannot join
- atrial fibrillation/flutter of frequent ectopic beats
- pregnancy and lactation
- terminal malignant disease, life expectancy <6 months
- limb amputation
- dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Association Between Sleep Blood Pressure Patterns and Blood Pressure Values in Daily Life - Usefulness of Novel BP Monitoring Methods
Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Ambulatory BP values are more strongly associated with target organ damage and cardiovascular (CVD) events than office values. In particular, nocturnal blood pressure level and reduction of BP during the night (dipping) have been recognised as predictors of cardiovascular complications. However, in current clinical practice, these parameters are derived from ABPM. HBPM represents an inexpensive alternative to ABPM, is preferred by patients and provides a more realistic assessment of BP during an individual's daily life. However, until recently, HBPM did not offer the possibility to measure nocturnal BP or dipping.
The development and validation of new BP devices, such as the NightView (OMRON Healthcare, HEM9601T-E3) could overcome this limitation, offering the possibility of home night-time BP measurements with minimal sleep disturbance. On the other hand the use of wearable devices such as HeartGuide (OMRON Healthcare, HEM-6411T-MAE) could provide BP values in daily life conditions. Compared with conventional HBP, typically measured in resting conditions at home, values obtained with wearable devices might be closer to daytime ABP values.
Read more
Combining nocturnal HBP, with daytime BP from wearable device could therefore allow the estimation of dipping status comparable with that provided by ABPM.
In order to compare HBP-derived dipping estimate with the gold standard ABPM-derived value, it is aimed to enrol patients with hypertension, assess their blood pressure profile with ABPM and provide them with both NightView and HeartGuide devices for 7 days. Then diurnal and nocturnal BP and dipping derived from standard 24-hour ABPM will be compared and the combination of NightView/HeartGuide in order to understand whether the latter can offer a reliable assessment of 24h BP pattern.
For a better phenotypization of nocturnal BP and dipping status the following determinants of nocturnal BP and dipping status will be also investigated: sleep quality, sleep duration, the presence of sleep disorders, salt consumption, catecholamine phenotype.
This study will offer the unique opportunity to understand whether such new HBP devices can be offered in alternative to ABPM in the assessment of 24h BP profile in patients with hypertension.
- Conditions
- Ambulatory Blood Pressure Monitoring, Home Blood Pressure Monitoring, Blood Pressure Determination, Arterial Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal blood pressure fall - wearable validated device
Average nocturnal blood pressure fall, assessed through a validated wearable device over 7 days
Measured: 1 week
Nocturnal blood pressure fall - ABPM
Average nocturnal blood pressure fall, assessed through ABPM over 7 days
Measured: 1 week
Secondary outcomes (4)
Average sleep duration
Average sleep duration in hours over 7 days, measured by simplified polysomnography
Measured: 1 week
Average systolic and diastolic blood pressure - wearable validated device
Average systolic and diastolic blood pressure in daily life conditions, assessed through a validated wearable device over 7 days
Measured: 1 week
Average systolic and diastolic blood pressure - ABPM
Average systolic and diastolic blood pressure in daily life conditions, assessed through ABPM over 7 days
Measured: 1 week
Leptin levels
Leptin levels at baseline
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion27 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ambulatory Blood Pressure MonitoringStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martino Pengo, MD, PhD, Study chair, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781256
- Sponsor's protocol ID
- 09J902
- Acronym
- CABER-NET
- Status last verified
- May 2024
- First submitted
- 16 Jun 2022
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Sleep Blood Pressure Patterns and Blood Pressure Values in Daily Life - Usefulness of Novel BP Monitoring Methods
- ClinicalTrials.gov ID
- NCT05781256
- Acronym / sponsor ID
- CABER-NET / 09J902
- Conditions
- Ambulatory Blood Pressure Monitoring, Home Blood Pressure Monitoring, Blood Pressure Determination, Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 23 Mar 2023 (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.
Out-of-office blood pressure (BP) measurement by means of ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) is recommended for the diagnosis and management of hypertension in the latest guidelines. Ambulatory BP values are more strongly associated with target organ damage and cardiovascular (CVD) events than office values. In particular, nocturnal blood pressure level and reduction of BP during the night (dipping) have been recognised as predictors of cardiovascular complications. However, in current clinical practice, these parameters are derived from ABPM. HBPM represents an inexpensive alternative to ABPM, is preferred by patients and provides a more realistic assessment of BP during an individual's daily life. However, until recently, HBPM did not offer the possibility to measure nocturnal BP or dipping.
The development and validation of new BP devices, such as the NightView (OMRON Healthcare, HEM9601T-E3) could overcome this limitation, offering the possibility of home night-time BP measurements with minimal sleep disturbance. On the other hand the use of wearable devices such as HeartGuide (OMRON Healthcare, HEM-6411T-MAE) could provide BP values in daily life conditions. Compared with conventional HBP, typically measured in resting conditions at home, values obtained with wearable devices might be closer to daytime ABP values.
Combining nocturnal HBP, with daytime BP from wearable device could therefore allow the estimation of dipping status comparable with that provided by ABPM.
In order to compare HBP-derived dipping estimate with the gold standard ABPM-derived value, it is aimed to enrol patients with hypertension, assess their blood pressure profile with ABPM and provide them with both NightView and HeartGuide devices for 7 days. Then diurnal and nocturnal BP and dipping derived from standard 24-hour ABPM will be compared and the combination of NightView/HeartGuide in order to understand whether the latter can offer a reliable assessment of 24h BP pattern.
For a better phenotypization of nocturnal BP and dipping status the following determinants of nocturnal BP and dipping status will be also investigated: sleep quality, sleep duration, the presence of sleep disorders, salt consumption, catecholamine phenotype.
This study will offer the unique opportunity to understand whether such new HBP devices can be offered in alternative to ABPM in the assessment of 24h BP profile in patients with hypertension.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * >18 years old * arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment * antihypertensive treatment stable over 2 weeks preceding enrolment * written informed consent Exclusion Criteria: * atrial fibrillation/flutter of frequent ectopic beats * pregnancy and lactation * terminal malignant disease, life expectancy <6 months * limb amputation * dementia
Key inclusion criteria (4 listed)
- >18 years old
- arterial hypertension defined as office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg or the presence of antihypertensive treatment
- antihypertensive treatment stable over 2 weeks preceding enrolment
- written informed consent
Key exclusion criteria (5 listed)
- atrial fibrillation/flutter of frequent ectopic beats
- pregnancy and lactation
- terminal malignant disease, life expectancy <6 months
- limb amputation
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nocturnal blood pressure fall - wearable validated device
Time frame: 1 week
Average nocturnal blood pressure fall, assessed through a validated wearable device over 7 days
Nocturnal blood pressure fall - ABPM
Time frame: 1 week
Average nocturnal blood pressure fall, assessed through ABPM over 7 days
4 secondary outcomes
Average sleep duration
Time frame: 1 week
Average systolic and diastolic blood pressure - wearable validated device
Time frame: 1 week
Average systolic and diastolic blood pressure - ABPM
Time frame: 1 week
Leptin levels
Time frame: At baseline
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 24 May 2024.
- Individual participant dataSharing planned: No
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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.
Martino Pengo, MD, PhD study chair
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ambulatory Blood Pressure Monitoring and Home Blood Pressure Monitoring, run by Istituto Auxologico Italiano at 1 site in Italy.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 May 2024. 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 Italy. 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?
Nocturnal blood pressure fall - wearable validated device (time frame: 1 week). 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?
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 24 May 2024.