Cumulative Blood Pressure Load and Left Ventricular Mass

NCT ID: NCT05465746

Last Updated: 2022-07-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-02-28

Brief Summary

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Delay in the diagnosis of systemic arterial hypertension (SAH) causes morbid hypertensive status with target organ damage (TOD). Screening and surveillance of SAH used to be performed through self-measurement of blood pressure (SMBP) or routinary in clinic blood pressure measurement (CBPM).

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).

Detailed Description

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Delayed diagnosis of SAH causes a morbid hypertensive state, with target-organ damage (TOD): brain, kidney, and heart. An early diagnosis and proper follow-up of patients with SAH prevents and reduces comorbidities associated with TOD. Screening and follow-up of SAH are traditionally performed by routine self-monitoring of blood pressure (HBPM) or clinic blood pressure measurement (CBPM).

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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Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Both sex
* Between 40 and 79 years old.
* Low or moderate cardiovascular risk according to the 3American Heart Association (AHA) criteria.

Exclusion Criteria

* Patients with TOD defined as: the history of cerebrovascular event (CVD); chronic kidney disease (CKD) with glomerular filtration rate (GFR) \<30 mL/min/1.73 m2 or under replacement therapy (renal dialysis).
* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Ecuatoriano del Corazón

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Ecuador

Central Contacts

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Patricia Delgado-Cedeño, MD

Role: CONTACT

+593 997829415

Miguel Puga-Tejada, MD

Role: CONTACT

+5491165003311

Facility Contacts

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Patricia Delgado-Cedeno, MD

Role: primary

+593997829415

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.

Reference Type RESULT
PMID: 27853165 (View on PubMed)

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.

Reference Type RESULT
PMID: 30568812 (View on PubMed)

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.

Reference Type RESULT
PMID: 30003702 (View on PubMed)

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.

Reference Type RESULT
PMID: 17144238 (View on PubMed)

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.

Reference Type RESULT
PMID: 32001477 (View on PubMed)

Other Identifiers

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IECOR002

Identifier Type: -

Identifier Source: org_study_id

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