Patterns of Cardiac Arrhythmia in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease With and Without Hemodialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patterns of Cardiac Arrhythmia In Patients With Chronic Kidney Disease at Sohag University Hospitals
Overview
Cardiovascular diseases remain the primary leading cause of death in patients on maintenance hemodialysis accounting for nearly 41% of deaths. Chronic kidney disease is associated with an excess of acquired arrhythmia of multiple types, and atrial fibrillation in particular. Sudden cardiac death is also more common in chronic kidney disease and accounts for around one- quarter of deaths in dialysis patients. The aim of the study is to evaluate the incidence, describe the patterns of cardiac arrhythmia and to determine the factors predisposing to cardiac arrhythmia in patients with chronic kidney disease with or without hemodialysis.
Detailed description
After obtaining written, informed consents, individuals are subjected to thorough clinical evaluation (age, sex, history of hypertension (HTN) or diabetes mellitus (DM)) and laboratory tests including complete blood count, urea, creatinine, glomerular filtration rate (eGFR) (calculated by CKD-EPI equation) , serum potassium, magnesium, calcium, phosphorus, parathyroid hormone (PTH), iron and total iron binding capacity (TIBC).
Twelve-lead ECG is performed and all ECGs are reviewed for the following parameters: heart rhythm, heart rate, frontal axis, P wave, PR interval, QRS duration, pathological Q wave, fragmented QRS morphology, ST-segment deviation, QT interval and T wave abnormality.
Primary outcome measures
- Detection of changes (already exsited) in heart rate (measured in beats/ minutes) and corrected QT interval (measured in milliseconds) from normal limits in patients with chronic kidney disease. [Time frame: Health survey distributed during 4 months to determine how many patients with chronic kidney disease have cardiac arrhythmia in hemodialysis unit and outpatient nephrology clinic at sohag university hospitals]
Eligibility criteria
Inclusion criteria
- Patients with CKD (no intercurrent illness or uremic symptoms, and not hospitalized in the previous 3 months) with renal replacement therapy on maintenance HD (three times/week for at least three months) or without renal replacement therapy, aged 18 or above.
Exclusion criteria
- Patients aged <18 years old.
- Patients on drugs that are known to prolong the QT interval (e.g., antibiotics as clarithromycin, antifungal as fluconazole, antiarrhythmics as amiodarone, antipsychotic as chlorpromazine)
- Patients with structural heart diseases (e.g.,significant valvular lesions )
- Patients with impaired left ventricular systolic functions (defined as EF< 50%
- Patients with malignancy, severe infection or sepsis.
- Patients with major bleeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
Egypt · 1 center
- Sohag university hospitals — Sohag
Identifiers
NCT: NCT07640919 · Soh-Med-26-5-5MS