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Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542526
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Sadeq, Assiut University

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

Condition or disease Intervention/treatment
Hypertension Device: electrogradiogram Device: ambulatory blood prussre

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.

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Study Type : Observational
Estimated Enrollment : 73 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Relationship of Different Electrocardiographic Parameters and Ambulatory Blood Pressure Parameters to Detect Left Ventricular Hypertrophy
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: electrogradiogram
    12 lead ecg ambulatory blood prussre
    Other Name: blood measuring device
  • Device: ambulatory blood prussre
    ambulatory blood pressure to measure blood pressure


Primary Outcome Measures :
  1. minimize complicate of hypertension [ Time Frame: 1 years ]
    screening with hypertensive patient



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All eligible patients attending the Hypertension outpatient clinic over two year duration starting from November 2018, will be consecutively enrolled
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542526


Contacts
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Contact: Yehia t Keshk, professor 20882335120 yehia@aun.edu.eg
Contact: Tarek a nagib, lecturer 201099975128 Tarkaf76@yahoo.com

Locations
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Egypt
AssiutU Recruiting
Assiut, Egypt
Contact: Yehia T Keshk, professor    20882335120    yehia@aun.edu.eg   
Contact: Tarek a nagib, lecturer    201099975128    Tarkaf76@yahoo.com   
Sponsors and Collaborators
Assiut University
Additional Information:
Publications:
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Responsible Party: Michael Sadeq, cardiology resident, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03542526    
Other Study ID Numbers: LVHTN
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: to maintain the privacy of the protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertrophy, Left Ventricular
Hypertrophy
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cardiomegaly
Heart Diseases