Clinical trial NCT05781256: Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life
Official title: Study on the Association Between Sleep Blood Pressure Patterns and Blood Pressure Values in Daily Life - Usefulness of Novel BP Monitoring Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ambulatory Blood Pressure Monitoring
Home Blood Pressure Monitoring
Blood Pressure Determination
Arterial Hypertension
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 173
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Nocturnal blood pressure fall - wearable validated device
timeFrame: 1 week
measure: Nocturnal blood pressure fall - ABPM
timeFrame: 1 week
Secondary outcomes:
measure: Average sleep duration
timeFrame: 1 week
measure: Average systolic and diastolic blood pressure - wearable validated device
timeFrame: 1 week
measure: Average systolic and diastolic blood pressure - ABPM
timeFrame: 1 week
measure: Leptin levels
timeFrame: At baseline
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Martino Pengo
state: MI
Study officials:
affiliation: Istituto Auxologico Italiano
name: Martino Pengo, MD, PhD
role: STUDY_CHAIR
References: