Ramipril in Pediatric Patients on Hemodialysis

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemodialysis

Treatments: Drug: Ramipril; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04582097

PHCL 65

Details and patient eligibility

About

The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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135 participants in 2 patient groups, including a placebo group

Ramipril

Experimental group

Description:

Ramipril, 2.5 mg daily, administered orally for 16 weeks

Treatment:

Drug: Ramipril

Placebo

Placebo Comparator group

Description:

Placebo, matched for the interventional drug, administered orally, daily for 16 weeks

Treatment:

Drug: placebo