Hemodialysis
Conditions
Keywords
angiotensin-convertting enzyme inhibitor, ramipril
Brief summary
The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis
Detailed description
Evaluate the effect of Ramipril on blood pressure, heart rate, Endothelial dysfunction and inflammatory markers in pediatric patients on regular hemodilaysis and the correlation of response with ACE I/D polymorphisms.
Interventions
DRUGRamipril
angiotensin-converting enzyme inhibitor
DRUGplacebo
same odor, color and size as the drug but without the active ingredient
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Patients \< 16 years old * Patients who have been on regular HD for 6 months or longer * Hypertension at enrollment
Exclusion criteria
* History of active connective tissue disease * Acute infection within 1 month prior to the study * Advanced liver disease * Gastrointestinal dysfunction requiring parental nutrition or active malignancy * Use of medications such as immunosuppressive drugs within 1 month prior to the study * Use of anti-inflammatory medications * Use of vitamin E at a dose higher than 60 IU per day or vitamin C higher than 500 mg per day * History of myocardial infarction or cerebrovascular event within 3 months prior to the study * History of ACE inhibitor-associated angioedema * Inability to discontinue ACE inhibitors or ARBs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| concentration of Asymmetric dimethylarginine (ADMA) | 16 weeks | marker of endothelial dysfunction |
| concentration of high-sensitivity C-reactive protein (Hs-CRP ) | 16 weeks | marker of inflammation |
Countries
Egypt
Outcome results
None listed