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Cumulative Blood Pressure Load and Left Ventricular Mass

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05465746
Enrollment
80
Registered
2022-07-20
Start date
2022-07-01
Completion date
2023-02-28
Last updated
2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension

Keywords

Ambulatory blood pressure monitoring, Blood pressure, Target organ damage, Left ventricular mass, Transthoracic echocardiography

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.

Interventions

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

DIAGNOSTIC_TESTThree-dimensional transthoracic echocardiography

Using an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index.

Sponsors

Instituto Ecuatoriano del Corazón
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
24-hour systolic and diastolic blood pressure (SBP & DBP)24 hoursThe 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.
Left ventricular mass index (LVMI)30 minutesLVMI 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.

Countries

Ecuador

Contacts

Primary ContactPatricia Delgado-Cedeño, MD
pdelgadodevargas@gmail.com+593 997829415
Backup ContactMiguel Puga-Tejada, MD
miguel.puga01@gmail.com+5491165003311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026