Predialytic Chronic Kidney DiseaseNCT05726071
Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease
An observational study of Predialytic Chronic Kidney Disease, run by Sohag University at 1 site in Egypt.
Trial summary
CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Predialytic Chronic Kidney Disease
- What is being tested?
- Holter
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Oct 2023
- 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 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: children with predialytic chronic kidney disease
Who may be able to join
- Age 1 to 15 year children with predialytic chronic kidney disease GFR.>15 ml\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages).
Who cannot join
- Age >15 year On regular dialysis GFR<15 ml\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant
Trial locations and contacts
1 site in 1 country.
Shaimaa M Mahmoud, Assistant professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag faculty of medicine
Sohag
Magdy M Amin, professor, (093)- 4602963, portal@med.sohag.edu.eg
About this study
CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after
Read the detailed description
This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia
- Conditions
- Predialytic Chronic Kidney Disease
- Being tested
- Holter
- Keywords
- Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HolterDevice
Also called ECG Fukuda Denshi CardiMax ECG device model FCP-7101
24 hour electrocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Sinus tachycardia or bradycardia
Measured: One year
changes in QT interval
Prolonged QT interval in ECG
Measured: One year
QRS duration
Increase or decrease in ECG
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Predialytic Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wethab Khaled Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726071
- Sponsor's protocol ID
- Soh-med-23-01-12
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shafi S, Saleem M, Anjum R, Abdullah W, Shafi T. ECG Abnormalities In Patients With Chronic Kidney Disease. J Ayub Med Coll Abbottabad. 2017 Jan-Mar;29(1):61-64.
PubMed 28712176Park S, Yum Y, Cha JJ, Joo HJ, Park JH, Hong SJ, Yu CW, Lim DS. Prevalence and Clinical Impact of Electrocardiographic Abnormalities in Patients with Chronic Kidney Disease. J Clin Med. 2022 Sep 15;11(18):5414. doi: 10.3390/jcm11185414.
PubMed 36143060Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
PubMed 15241746
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05726071
- Acronym / sponsor ID
- Soh-med-23-01-12
- Conditions
- Predialytic Chronic Kidney Disease
- Keywords
- Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after
Detailed description
This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with predialytic chronic kidney disease
Key inclusion criteria (1 listed)
- Age 1 to 15 year children with predialytic chronic kidney disease GFR.>15 ml\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages).
Key exclusion criteria (1 listed)
- Age >15 year On regular dialysis GFR<15 ml\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant
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 |
|---|---|---|
| HolterAlso: ECG Fukuda Denshi CardiMax ECG device model FCP-710124 hour electrocardiography | Device | – |
Primary outcome
Heart rate variability
Time frame: One year
Sinus tachycardia or bradycardia
changes in QT interval
Time frame: One year
Prolonged QT interval in ECG
QRS duration
Time frame: One year
Increase or decrease in ECG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Background: PubMed 28712176Shafi S, Saleem M, Anjum R, Abdullah W, Shafi T. ECG Abnormalities In Patients With Chronic Kidney Disease. J Ayub Med Coll Abbottabad. 2017 Jan-Mar;29(1):61-64.
- Background: PubMed 36143060Park S, Yum Y, Cha JJ, Joo HJ, Park JH, Hong SJ, Yu CW, Lim DS. Prevalence and Clinical Impact of Electrocardiographic Abnormalities in Patients with Chronic Kidney Disease. J Clin Med. 2022 Sep 15;11(18):5414. doi: 10.3390/jcm11185414.
- Background: PubMed 15241746Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
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.
Shaimaa M Mahmoud, Assistant professor contact
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 Predialytic Chronic Kidney Disease, run by Sohag 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 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 13 Feb 2023. 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 Wethab K Mohamed, Pediatric resident (+2001090090162, Wethab011226@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: One year). The study lists 3 primary outcomes in all. 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 NCT05726071, which also lists 3 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 13 Feb 2023.