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

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Recruiting

CT.gov ID

NCT05781256

Collaborator

(none)

155

Enrollment

Location

Anticipated Duration (Months)

15.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ambulatory Blood Pressure Monitoring Home Blood Pressure Monitoring Blood Pressure Determination Arterial Hypertension

Study Design

Study Type:

Observational

Anticipated Enrollment :

155 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Study on the Association Between Sleep Blood Pressure Patterns and Blood Pressure Values in Daily Life - Usefulness of Novel BP Monitoring Methods

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Outcome Measures

Primary Outcome Measures

Nocturnal blood pressure fall - wearable validated device [1 week]
Average nocturnal blood pressure fall, assessed through a validated wearable device over 7 days
Nocturnal blood pressure fall - ABPM [1 week]
Average nocturnal blood pressure fall, assessed through ABPM over 7 days

Secondary Outcome Measures

Average sleep duration [1 week]
Average sleep duration in hours over 7 days, measured by simplified polysomnography
Average systolic and diastolic blood pressure - wearable validated device [1 week]
Average systolic and diastolic blood pressure in daily life conditions, assessed through a validated wearable device over 7 days
Average systolic and diastolic blood pressure - ABPM [1 week]
Average systolic and diastolic blood pressure in daily life conditions, assessed through ABPM over 7 days
Leptin levels [At baseline]
Leptin levels at baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martino Pengo	Milan	MI	Italy	20149

Sponsors and Collaborators

Istituto Auxologico Italiano

Investigators

Study Chair: Martino Pengo, MD, PhD, Istituto Auxologico Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05781256

Other Study ID Numbers:

09J902

First Posted:

Mar 23, 2023

Last Update Posted:

Mar 23, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Mar 23, 2023