Cumulative Blood Pressure Load and Left Ventricular Mass
NCT ID: NCT05465746
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2022-07-01
2023-02-28
Brief Summary
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It is essential to determine the correlation between the cumulative blood pressure load through ABPM and the left ventricular mass identified by three-dimensional transthoracic ultrasound (3D-TTE). We postulate a directly proportional and statistically significant association between cumulative blood pressure load and left ventricular mass (LVM).
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Detailed Description
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Ambulatory blood pressure monitoring (ABPM) consists of measuring BP every fifteen and thirty minutes for twenty-four hours, using a sphygmomanometer adapted to a portable monitor, which led to the recognition of SAH phenotypes often not identified through SMBP or CBPM. The ABPM offers three types of information: a) the mean BP in twenty-four hours, day and night; b) BP variability; and c) cumulative BP load. Cumulative BP load is the percentage of BP measurements above 135/85 mmHg.
Increased LVM is a consequence of chronic hypertension and early sign of TOD at the cardiac level. It has been shown that the variability in nocturnal diastolic BP correlates significantly with LVM, independently of mean BP load. It is likely that an elevated BP load according to ABPM correlates with higher TOB; however, at the moment, there is no standardized value of BP load that allows predicting the increase in the LVM. For this reason, a standardized cut-off of cumulative BP load is helpful for understanding ABPM in the screening SAH.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adults with an indication of SAH screening
Patients who attend the physician's office or the emergency room (ER) with signs and symptoms of high systemic arterial blood pressure will be indicated for ABPM and TTE
24-hour ambulatory blood pressure monitoring (ABPM)
Using a WatchBPO3 AFIB device (Microlife) placed around the left upper arm, BP measurements will be recorded every twenty minutes during the day and every thirty minutes at night, over a twenty-four-hour period. The device will automatically calculate the BP and the twenty-four-hour average BP, day, night, and cumulative BP load
Three-dimensional transthoracic echocardiography
Using an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index.
Interventions
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24-hour ambulatory blood pressure monitoring (ABPM)
Using a WatchBPO3 AFIB device (Microlife) placed around the left upper arm, BP measurements will be recorded every twenty minutes during the day and every thirty minutes at night, over a twenty-four-hour period. The device will automatically calculate the BP and the twenty-four-hour average BP, day, night, and cumulative BP load
Three-dimensional transthoracic echocardiography
Using an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index.
Eligibility Criteria
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Inclusion Criteria
* Between 40 and 79 years old.
* Low or moderate cardiovascular risk according to the 3American Heart Association (AHA) criteria.
Exclusion Criteria
* History of chronic liver disease with a Child-Pugh B or C.
* Dependence on alcohol or psychotropic drugs.
* History of cancer, regardless of stage or time of treatment.
* Patients who do not wish to participate in this study.
40 Years
79 Years
ALL
No
Sponsors
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Instituto Ecuatoriano del Corazón
OTHER
Responsible Party
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Principal Investigators
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Patricia Delgado-Cedeño, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Ecuatoriano del Corazón
Locations
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Instituto Ecuatoriano del Corazón
Guayaquil, Guayas, Ecuador
Countries
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Central Contacts
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Facility Contacts
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References
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Cuspidi C, Sala C, Casati A, Bombelli M, Grassi G, Mancia G. Clinical and prognostic value of hypertensive cardiac damage in the PAMELA Study. Hypertens Res. 2017 Apr;40(4):329-335. doi: 10.1038/hr.2016.153. Epub 2016 Nov 17.
Mustafa ER, Istratoaie O, Musetescu R. Blood Pressure Variability and Left Ventricular Mass in Hypertensive Patients. Curr Health Sci J. 2016 Jan-Mar;42(1):47-50. doi: 10.12865/CHSJ.42.01.07. Epub 2016 Mar 29.
O'Brien E, White WB, Parati G, Dolan E. Ambulatory blood pressure monitoring in the 21st century. J Clin Hypertens (Greenwich). 2018 Jul;20(7):1108-1111. doi: 10.1111/jch.13275.
Uallachain GN, Murphy G, Avalos G. The RAMBLER study: the role of ambulatory blood pressure measurement in routine clinical practice: a cross-sectional study. Ir Med J. 2006 Oct;99(9):276-9.
Jones NR, McCormack T, Constanti M, McManus RJ. Diagnosis and management of hypertension in adults: NICE guideline update 2019. Br J Gen Pract. 2020 Jan 30;70(691):90-91. doi: 10.3399/bjgp20X708053. Print 2020 Feb. No abstract available.
Other Identifiers
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IECOR002
Identifier Type: -
Identifier Source: org_study_id
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