Cumulative Blood Pressure Load and Left Ventricular Mass

Arterial Hypertension Clinical Trial

Official title:

Correlation Between 24-hour Blood Pressure Load and Left Ventricular Mass: the CAPAMAVI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05465746
• Other study ID #: IECOR002
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2022
• Source: Instituto Ecuatoriano del Corazón
• Contact: Patricia Delgado-Cedeño, MD
• Phone: +593 997829415
• Email: pdelgadodevargas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano del Corazón	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano del Corazón

Country where clinical trial is conducted

Ecuador, 

References & Publications (5)

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. Review. — View 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. Review. Erratum in: Br J Gen Pract. 2020 — View Citation

Mustafa ER, Istratoaie O, Mu?etescu 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour systolic and diastolic blood pressure (SBP & DBP)	The ABPM study will allow obtaining results of the mean BP in 24 hours, day and night; BP variability; and the pressure load. According to the international HBP guideline, normal BP will be considered below 135/85 mmHg during the twenty-four hours or during the day or below 120/70 mmHg at night. BP load is the percentage of BP measurements above 135/85 mmHg.	24 hours
Primary	Left ventricular mass index (LVMI)	LVMI will be considered high when it exceeds 115 g/m2 of the body surface in men and 95 g/m2 in women. Each 3D-TTE will be performed by an echocardiographic cardiologist with experience in more than 5,000 3D-TTEs performed on adults annually. For the LVMI estimate to be as unbiased as possible, she will perform the 3D-TTE blind to any clinical history before completing the ABPM.	30 minutes