Clinical trial NCT05465746: Cumulative Blood Pressure Load and Left Ventricular Mass
Official title: Correlation Between 24-hour Blood Pressure Load and Left Ventricular Mass: the CAPAMAVI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Hypertension
Keywords: Ambulatory blood pressure monitoring
Blood pressure
Target organ damage
Left ventricular mass
Transthoracic echocardiography
Lead sponsor: Instituto Ecuatoriano del Corazón
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with an indication of SAH screening.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hour systolic and diastolic blood pressure (SBP & DBP)
timeFrame: 24 hours
measure: Left ventricular mass index (LVMI)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Instituto Ecuatoriano del Corazón
state: Guayas
Study officials:
affiliation: Instituto Ecuatoriano del Corazón
name: Patricia Delgado-Cedeño, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.