Ramipril in Pediatric Patients on Hemodialysis
- Registration Number
- NCT04582097
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
- Patients < 16 years old
- Patients who have been on regular HD for 6 months or longer
- Hypertension at enrollment
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ramipril Ramipril Ramipril, 2.5 mg daily, administered orally for 16 weeks Placebo placebo Placebo, matched for the interventional drug, administered orally, daily for 16 weeks
- Primary Outcome Measures
Name Time Method concentration of high-sensitivity C-reactive protein (Hs-CRP ) 16 weeks marker of inflammation
concentration of Asymmetric dimethylarginine (ADMA) 16 weeks marker of endothelial dysfunction
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ain Shams University Hospital
🇪🇬Cairo, Egypt