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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05002010
Other study ID # LVH in CKD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2022
Est. completion date December 2022

Study information

Verified date February 2022
Source Assiut University
Contact Heba Mohammed
Phone 01553466968
Email Hebamohammed180@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assess the prevalence and features of left ventricular hypertrophy in patients with chronic kidney disease (CKD) taking into account gender differences and stage of CKD. To detect factors those predict LVH in CKD. *to assess the right ventricle dysfunction in CKD .


Description:

The number of patients with chronic kidney disease (CKD) is growing worldwide, while patients with impaired renal function are at high or very high risk for developing cardiovascular disease (CVD). Mortality due to CVD in patients with CKD is 1020 times higher than that in the general population, and the likelihood of developing cardiovascular complications (CVC) is several times higher than the risk of end-stage CKD{1} In CKD cardiovascular disease abnormalities are due to volume overload, hypertension, endothelia dysfunction, inflammation, uremic pericarditis cardiomyopathy, anemia, dyslipidemia and oxidativel stress{2} Left ventricular hypertrophy (LVH) is a key feature that allows you to get an accurate picture of systolic-diastolic lesions of the left heart in patients with CKD and therefore is one of the most important factors in the development of adverse CVC LVH is initially formed as an adaptive process aimed at maintaining normal heart function under conditions of myocardial overload by pressure or volume, but then acquires the character of pathological adaptation, becoming the structural basis of heart failure, myocardial ischemia and cardiac arrhythmias {3}. It was shown that the probability of LVH increases already with a moderate decrease in eGFR and increases further as CKD progresses, reaching a maximum in the terminal stage [4]. . in CKD LVH is associated with increased mortality and the risk of adverse outcomes, especially at the terminal stage of CKD{5-6}


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with chronic renal disease (CKD) aged between 16 and 65 years will be included. 2- CKD are diagnosed based on criteria proposed by KDIGO (Kidney Disease: Improving Global Outcomes) in 2002 Exclusion Criteria: - Patients with structural heart disease (congenital or valvular heart disease). Patients with primary hypertension. Patients with obstructive or restrictive lung disease.

Study Design


Intervention

Device:
Echo
Measure the Left ventricle (LV): IVS (interventricular septum), LVEDD(left ventricle end diastolic dimension ),LVESD((left ventricle end systolic dimension ), PWD(posterior wall dimension), LV systolic dysfunction and LV diastolic dysfunction.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Vallianou NG, Mitesh S, Gkogkou A, Geladari E. Chronic Kidney Disease and Cardiovascular Disease: Is there Any Relationship? Curr Cardiol Rev. 2019;15(1):55-63. doi: 10.2174/1573403X14666180711124825. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Detecting the prevalence of LVH in CKD. The types of LVH in different stages of CKD. Risk factors of LVH in different stages of CKD through study completion, an average of 1 year".
Secondary The types of LVH in different stages of CKD. Risk factors of LVH in different stages of CKD through study completion, an average of 1 year".
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