HypertensionNCT03542526
Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy
An observational study of Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- electrogradiogram and ambulatory blood prussre
- Type of treatment
- Medical device
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Dec 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All eligible patients attending the Hypertension outpatient clinic over two year duration starting from November 2018, will be consecutively enrolled
Who may be able to join
- Patients ranging from 20t o 80 years attending the hypertension outpatient clinic for ambulatory blood pressure measurement will be consecutively enrolled
Who cannot join
- Patients with ischemic heart disease.
- Patients with advanced respiratory, renal, or hepatic disease
- Patients with uninterpretable ECG or ABPM recordings
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut
Yehia T Keshk, professor, 20882335120, yehia@aun.edu.eg
Tarek a nagib, lecturer, 201099975128, Tarkaf76@yahoo.com
About this study
To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension.
Read the detailed description
Arterial hypertension is a major cause of coronary heart disease, stroke, and heart failure. Several studies have shown that left ventricular hypertrophy is an important risk factor in patients with hypertension, leading to a fivefold to 10-fold increase in cardiovascular risk,1 2 3 4 5 which is similar to the increase seen in patients with a history of myocardial infarction.6 The presence of left ventricular hypertrophy, in addition to hypertension, thus has important implications for assessing risk and managing patients, including decisions on interventions other than antihypertensive treatment, such as lipid lowering treatment and lifestyle modifications.7 8 Accurate and early diagnosis of left ventricular hypertrophy is therefore an important component of the care of patients with hypertension.
Decisions about treatment should be based on assessments of hypertensive target organ damage and overall cardiovascular risk. The appropriate diagnostic work-up of suspected left ventricular hypertrophy in patients with hypertension is less clear, however. There is many electrocardiographic indexes for the diagnosis of left ventricular hypertrophy, based on the standard 12 lead electrocardiogram, have been described. Many of the proposed indexes have remained anecdotal, but others are commonly used, including the Sokolow-Lyon index,9 the Cornell voltage index,10 the Cornell product index,11 the Gubner index,12 and the Romhilt-Estes scores.13 However, debate about their comparative diagnostic value continues.14 15 We did a systematic review to clarify the accuracy of different electrocardiographic indexes, with emphasis on their ability to rule out left ventricular hypertrophy in patients with arterial hypertension.
- Conditions
- Hypertension
- Being tested
- electrogradiogram, ambulatory blood prussre
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrogradiogramDevice
Also called blood measuring device
12 lead ecg ambulatory blood prussre
ambulatory blood prussreDevice
ambulatory blood pressure to measure blood pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
minimize complicate of hypertension
screening with hypertensive patient
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sadeq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542526
- Sponsor's protocol ID
- LVHTN
- Status last verified
- May 2018
- First submitted
- 27 Mar 2018
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to maintain the privacy of the protocol
Publications
Jain A, Tandri H, Dalal D, Chahal H, Soliman EZ, Prineas RJ, Folsom AR, Lima JA, Bluemke DA. Diagnostic and prognostic utility of electrocardiography for left ventricular hypertrophy defined by magnetic resonance imaging in relationship to ethnicity: the Multi-Ethnic Study of Atherosclerosis (MESA). Am Heart J. 2010 Apr;159(4):652-8. doi: 10.1016/j.ahj.2009.12.035.
PubMed 20362725Pewsner D, Juni P, Egger M, Battaglia M, Sundstrom J, Bachmann LM. Accuracy of electrocardiography in diagnosis of left ventricular hypertrophy in arterial hypertension: systematic review. BMJ. 2007 Oct 6;335(7622):711. doi: 10.1136/bmj.39276.636354.AE. Epub 2007 Aug 28.
PubMed 17726091
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy
- ClinicalTrials.gov ID
- NCT03542526
- Acronym / sponsor ID
- LVHTN
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 May 2018 (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.
To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension.
Detailed description
Arterial hypertension is a major cause of coronary heart disease, stroke, and heart failure. Several studies have shown that left ventricular hypertrophy is an important risk factor in patients with hypertension, leading to a fivefold to 10-fold increase in cardiovascular risk,1 2 3 4 5 which is similar to the increase seen in patients with a history of myocardial infarction.6 The presence of left ventricular hypertrophy, in addition to hypertension, thus has important implications for assessing risk and managing patients, including decisions on interventions other than antihypertensive treatment, such as lipid lowering treatment and lifestyle modifications.7 8 Accurate and early diagnosis of left ventricular hypertrophy is therefore an important component of the care of patients with hypertension.
Decisions about treatment should be based on assessments of hypertensive target organ damage and overall cardiovascular risk. The appropriate diagnostic work-up of suspected left ventricular hypertrophy in patients with hypertension is less clear, however. There is many electrocardiographic indexes for the diagnosis of left ventricular hypertrophy, based on the standard 12 lead electrocardiogram, have been described. Many of the proposed indexes have remained anecdotal, but others are commonly used, including the Sokolow-Lyon index,9 the Cornell voltage index,10 the Cornell product index,11 the Gubner index,12 and the Romhilt-Estes scores.13 However, debate about their comparative diagnostic value continues.14 15 We did a systematic review to clarify the accuracy of different electrocardiographic indexes, with emphasis on their ability to rule out left ventricular hypertrophy in patients with arterial hypertension.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All eligible patients attending the Hypertension outpatient clinic over two year duration starting from November 2018, will be consecutively enrolled
Key inclusion criteria (1 listed)
- Patients ranging from 20t o 80 years attending the hypertension outpatient clinic for ambulatory blood pressure measurement will be consecutively enrolled
Key exclusion criteria (3 listed)
- Patients with ischemic heart disease.
- Patients with advanced respiratory, renal, or hepatic disease
- Patients with uninterpretable ECG or ABPM recordings
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 |
|---|---|---|
| electrogradiogramAlso: blood measuring device12 lead ecg ambulatory blood prussre | Device | – |
| ambulatory blood prussreambulatory blood pressure to measure blood pressure | Device | – |
Primary outcome
minimize complicate of hypertension
Time frame: 1 years
screening with hypertensive patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Background: PubMed 20362725Jain A, Tandri H, Dalal D, Chahal H, Soliman EZ, Prineas RJ, Folsom AR, Lima JA, Bluemke DA. Diagnostic and prognostic utility of electrocardiography for left ventricular hypertrophy defined by magnetic resonance imaging in relationship to ethnicity: the Multi-Ethnic Study of Atherosclerosis (MESA). Am Heart J. 2010 Apr;159(4):652-8. doi: 10.1016/j.ahj.2009.12.035.
- Background: PubMed 17726091Pewsner D, Juni P, Egger M, Battaglia M, Sundstrom J, Bachmann LM. Accuracy of electrocardiography in diagnosis of left ventricular hypertrophy in arterial hypertension: systematic review. BMJ. 2007 Oct 6;335(7622):711. doi: 10.1136/bmj.39276.636354.AE. Epub 2007 Aug 28.
- Diagnostic and Prognostic Utility of ECG for Left Ventricular Hypertrophy Defined by MRI in Relationship to Ethnicity: The Multi-Ethnic Study of Atherosclerosis (MESA)Link provided by the sponsor.
- Accuracy of electrocardiography in diagnosis of left ventricular hypertrophy in arterial hypertension: systematic reviewLink provided by the sponsor.
- Ambulatory blood pressureLink provided by the sponsor.
- Individual participant dataSharing planned: No. to maintain the privacy of the protocol
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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.
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 Hypertension, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 3 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 31 May 2018. 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 Egypt. 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 Yehia t Keshk, professor (20882335120, yehia@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
minimize complicate of hypertension (time frame: 1 years). 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 NCT03542526, which also lists 2 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 31 May 2018.