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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03542526
Other study ID # LVHTN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2022

Study information

Verified date May 2018
Source Assiut University
Contact Yehia t Keshk, professor
Phone 20882335120
Email yehia@aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To review the accuracy of electrocardiography in screening for left ventricular hypertrophy in patients with hypertension.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 73
Est. completion date December 31, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Patients ranging from 20t o 80 years attending the hypertension outpatient clinic for ambulatory blood pressure measurement will be consecutively enrolled

Exclusion Criteria:

1. Patients with ischemic heart disease.

2. Patients with advanced respiratory, renal, or hepatic disease

3. Patients with uninterpretable ECG or ABPM recordings

Study Design


Related Conditions & MeSH terms


Intervention

Device:
electrogradiogram
12 lead ecg ambulatory blood prussre
ambulatory blood prussre
ambulatory blood pressure to measure blood pressure

Locations

Country Name City State
Egypt AssiutU Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Pewsner D, Jüni P, Egger M, Battaglia M, Sundström J, Bachmann LM. Accuracy of electrocardiography in diagnosis of left ventricular hypertrophy in arterial hypertension: systematic review. BMJ. 2007 Oct 6;335(7622):711. Epub 2007 Aug 28. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary minimize complicate of hypertension screening with hypertensive patient 1 years
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