Arterial HypertensionNCT05465746
Cumulative Blood Pressure Load and Left Ventricular Mass
An observational study of Arterial Hypertension, run by Instituto Ecuatoriano del Corazón at 1 site in Ecuador.
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). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Arterial Hypertension
- What is being tested?
- 24-hour ambulatory blood pressure monitoring (ABPM) and Three-dimensional transthoracic echocardiography
- How many people
- 80 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Jul 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with an indication of SAH screening.
Who may be able to join
- Both sex
- Between 40 and 79 years old.
- Low or moderate cardiovascular risk according to the 3American Heart Association (AHA) criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Instituto Ecuatoriano del Corazón
Guayaquil, Guayas, 090112
Patricia Delgado-Cedeno, MD, +593997829415, pdelgadodevargas@gmail.com
About this study
Official title: Correlation Between 24-hour Blood Pressure Load and Left Ventricular Mass: the CAPAMAVI
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).
Read the 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.
- Conditions
- Arterial Hypertension
- Being tested
- 24-hour ambulatory blood pressure monitoring (ABPM), Three-dimensional transthoracic echocardiography
- Keywords
- Ambulatory blood pressure monitoring, Blood pressure, Target organ damage, Left ventricular mass, Transthoracic echocardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour ambulatory blood pressure monitoring (ABPM)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 echocardiographyDiagnostic test
Using an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM); Diagnostic Test: Three-dimensional transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano del Corazón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Delgado-Cedeño, MD, Principal investigator, Instituto Ecuatoriano del Corazón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465746
- Sponsor's protocol ID
- IECOR002
- Status last verified
- Jul 2022
- First submitted
- 16 Jul 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27853165Mustafa 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.
PubMed 30568812O'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.
PubMed 30003702Uallachain 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.
PubMed 17144238Jones 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.
PubMed 32001477
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between 24-hour Blood Pressure Load and Left Ventricular Mass: the CAPAMAVI
- ClinicalTrials.gov ID
- NCT05465746
- Acronym / sponsor ID
- IECOR002
- Conditions
- Arterial Hypertension
- Keywords
- Ambulatory blood pressure monitoring, Blood pressure, Target organ damage, Left ventricular mass, Transthoracic echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano del CorazónUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with an indication of SAH screening | – | Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM), Diagnostic Test: Three-dimensional transthoracic echocardiographyPatients 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 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with an indication of SAH screening.
Key inclusion criteria (3 listed)
- Both sex
- Between 40 and 79 years old.
- Low or moderate cardiovascular risk according to the 3American Heart Association (AHA) criteria.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Adults with an indication of SAH screening |
| Three-dimensional transthoracic echocardiographyUsing an EPIQ CVx (Philips) echocardiograph with an ultrasound sector transducer, 3D-TTE will be performed to assess the LVM index. | Diagnostic test | Adults with an indication of SAH screening |
Primary outcome
24-hour systolic and diastolic blood pressure (SBP & DBP)
Time frame: 24 hours
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.
Left ventricular mass index (LVMI)
Time frame: 30 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Results publication: PubMed 27853165Cuspidi 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.
- Results publication: PubMed 30568812Mustafa 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.
- Results publication: PubMed 30003702O'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.
- Results publication: PubMed 17144238Uallachain 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.
- Results publication: PubMed 32001477Jones 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Delgado-Cedeño, MD principal investigator
Instituto Ecuatoriano del Corazón
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension, run by Instituto Ecuatoriano del Corazón at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Delgado-Cedeño, MD (+593 997829415, pdelgadodevargas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour systolic and diastolic blood pressure (SBP & DBP) (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.