Ramipril in Pediatric Patients on Hemodialysis

Hemodialysis Clinical Trial

Official title:

Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582097
• Other study ID #: PHCL 65
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: October 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 28, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Drug:
• Ramipril
angiotensin-converting enzyme inhibitor
• placebo
same odor, color and size as the drug but without the active ingredient

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concentration of Asymmetric dimethylarginine (ADMA)	marker of endothelial dysfunction	16 weeks
Primary	concentration of high-sensitivity C-reactive protein (Hs-CRP )	marker of inflammation	16 weeks