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Completed

NCT Number: NCT04582097

Ramipril in Pediatric Patients on Hemodialysis

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

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Key information

Conditions

Hemodialysis

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramipril

Drug

angiotensin-converting enzyme inhibitor

Other names: Tritace

Placebo

Drug

same odor, color and size as the drug but without the active ingredient

Primary outcomes

  1. concentration of Asymmetric dimethylarginine (ADMA)

    Time frame: 16 weeks

    marker of endothelial dysfunction

  2. concentration of high-sensitivity C-reactive protein (Hs-CRP )

    Time frame: 16 weeks

    marker of inflammation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 9, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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