Cumulative Blood Pressure Load and Left Ventricular Mass
Correlation Between 24-hour Blood Pressure Load and Left Ventricular Mass: the CAPAMAVI
1 other identifier
observational
80
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 16, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedJuly 20, 2022
July 1, 2022
6 months
July 16, 2022
July 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
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
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
Using an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index.
Eligibility Criteria
Adults with an indication of SAH screening.
You may qualify if:
- Both sex
- Between 40 and 79 years old.
- Low or moderate cardiovascular risk according to the 3American Heart Association (AHA) criteria.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Ecuatoriano del Corazón
Guayaquil, Guayas, 090112, Ecuador
Related 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.
PMID: 27853165RESULTMustafa 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.
PMID: 30568812RESULTO'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.
PMID: 30003702RESULTUallachain 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.
PMID: 17144238RESULTJones 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.
PMID: 32001477RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Delgado-Cedeño, MD
Instituto Ecuatoriano del Corazón
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2022
First Posted
July 20, 2022
Study Start
July 1, 2022
Primary Completion
December 31, 2022
Study Completion
February 28, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share