Ramipril in Pediatric Patients on Hemodialysis
Impact of Angiotensin-converting Enzyme Inhibitor on Pediatric Hemodialysis Patients
1 other identifier
interventional
135
1 country
1
Brief Summary
The aim of the study is to evaluate the effect of Ramipril in pediatric patients on regular hemodilaysis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 3, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedOctober 14, 2020
October 1, 2020
3 months
October 3, 2020
October 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
concentration of Asymmetric dimethylarginine (ADMA)
marker of endothelial dysfunction
16 weeks
concentration of high-sensitivity C-reactive protein (Hs-CRP )
marker of inflammation
16 weeks
Study Arms (2)
Ramipril
EXPERIMENTALRamipril, 2.5 mg daily, administered orally for 16 weeks
Placebo
PLACEBO COMPARATORPlacebo, matched for the interventional drug, administered orally, daily for 16 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients \< 16 years old
- Patients who have been on regular HD for 6 months or longer
- Hypertension at enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Hospital
Cairo, Egypt
Related Publications (1)
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.
PMID: 35686561DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ain Sh University
university
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant lecturer
Study Record Dates
First Submitted
October 3, 2020
First Posted
October 9, 2020
Study Start
December 1, 2018
Primary Completion
March 1, 2019
Study Completion
February 28, 2020
Last Updated
October 14, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share