Ramipril in Pediatric Patients on Hemodialysis

NCT ID: NCT04582097

Last Updated: 2020-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ramipril

Ramipril, 2.5 mg daily, administered orally for 16 weeks

Group Type EXPERIMENTAL

Ramipril

Intervention Type DRUG

angiotensin-converting enzyme inhibitor

Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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Ramipril

angiotensin-converting enzyme inhibitor

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Tritace

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Areej Mohamed Ateya

Assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ain Sh University

Role: PRINCIPAL_INVESTIGATOR

university

Locations

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Ain Shams University Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Ateya AM, El Hakim I, Shahin SM, El Borolossy R, Kreutz R, Sabri NA. Effects of Ramipril on Biomarkers of Endothelial Dysfunction and Inflammation in Hypertensive Children on Maintenance Hemodialysis: the SEARCH Randomized Placebo-Controlled Trial. Hypertension. 2022 Aug;79(8):1856-1865. doi: 10.1161/HYPERTENSIONAHA.122.19312. Epub 2022 Jun 10.

Reference Type DERIVED
PMID: 35686561 (View on PubMed)

Other Identifiers

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PHCL 65

Identifier Type: -

Identifier Source: org_study_id

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