Novel BP Monitoring Methods to Study the Association Between Sleep BP Patterns and BP Values in Daily Life (CABER-NET)

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.

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 Overview

• Status: Completed
• Conditions: Arterial Hypertension; Ambulatory Blood Pressure Monitoring; Blood Pressure Determination; Home Blood Pressure Monitoring

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20149
      • Martino Pengo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal blood pressure fall - wearable validated device	Average nocturnal blood pressure fall, assessed through a validated wearable device over 7 days	1 week
Nocturnal blood pressure fall - ABPM	Average nocturnal blood pressure fall, assessed through ABPM over 7 days	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average sleep duration	Average sleep duration in hours over 7 days, measured by simplified polysomnography	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	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	1 week
Leptin levels	Leptin levels at baseline	At baseline

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Investigators: Study Chair: Martino Pengo, MD, PhD, Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): April 27, 2024

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 09J902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No