Left Ventricular HypertrophyNCT05002010
Left Ventricular Hypertrophy Among Chronic Kidney Disease Patients in Assiut University Hospital
An observational study of Left Ventricular Hypertrophy and Chronic Kidney Diseases, run by Assiut University.
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 . Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Left Ventricular Hypertrophy, Chronic Kidney Diseases
- What is being tested?
- Echo
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients with structural heart disease (congenital or valvular heart disease). Patients with primary hypertension. Patients with obstructive or restrictive lung disease.
Trial locations and contacts
No sites are listed yet.
About this study
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 .
Read the detailed 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}
- Being tested
- Echo
- Medical subject headings
- Hypertrophy, Left Ventricular, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchoDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year".
Secondary outcomes (1)
The types of LVH in different stages of CKD. Risk factors of LVH in different stages of CKD
Measured: through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study startFeb 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular HypertrophyStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002010
- Sponsor's protocol ID
- LVH in CKD
- Status last verified
- Feb 2022
- First submitted
- 24 Jul 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29992892
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Hypertrophy Among Chronic Kidney Disease Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05002010
- Acronym / sponsor ID
- LVH in CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Aug 2021 (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.
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 .
Detailed 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}
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with structural heart disease (congenital or valvular heart disease). Patients with primary hypertension. Patients with obstructive or restrictive lung disease.
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 |
|---|---|---|
| EchoMeasure 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. | Device | – |
Primary outcome
Detecting the prevalence of LVH in CKD.
Time frame: through study completion, an average of 1 year".
The types of LVH in different stages of CKD. Risk factors of LVH in different stages of CKD
1 secondary outcome
The types of LVH in different stages of CKD. Risk factors of LVH in different stages of CKD
Time frame: through study completion, an average of 1 year".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 29992892Vallianou 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.
Related trials for Left Ventricular Hypertrophy
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
Active, not recruiting
Sodium Lowering Vascular Effects Trial
Endothelial Dysfunction, Vascular Stiffness
RecruitingObservational study
Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
Obstructive Coronary Artery Disease, Left Ventricular Hypertrophy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Hypertrophy and Chronic Kidney Diseases, run by Assiut University.
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 2 inclusion and 1 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Heba Mohammed (01553466968, Hebamohammed180@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detecting the prevalence of LVH in CKD. (time frame: through study completion, an average of 1 year".). 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 NCT05002010, which also lists 1 linked publication.
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 22 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.