Rapid Versus Prolonged Inpatient Up-Titration of Captopril
1 other identifier
interventional
50
1 country
1
Brief Summary
The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 26, 2008
CompletedFirst Posted
Study publicly available on registry
August 27, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 27, 2008
August 1, 2008
1 year
August 26, 2008
August 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of patients reaching a target dose of 1mg/kg/dose (given three times a day).
1 year
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Pediatric cardiology in-patients at The Hospital for Sick Children
- Primary physician has decided to commence ACEi (the division has agreed that our institutional choice will be to start patients on captopril and up-titrate to optimal dose before converting to other ACEi)
- Patients who have been initiated on captopril within the prior 24 hours, but have not yet started up-titration, will be eligible to be randomized
You may not qualify if:
- Known sensitivity to ACEi
- Infants on the neonatal intensive care unit
- Treatment with any ACEi for more than 24 hours within the preceding 6 months
- Age \> 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
Related Publications (1)
Roche SL, Timberlake K, Manlhiot C, Balasingam M, Wilson J, George K, McCrindle BW, Kantor PF. Angiotensin-Converting Enzyme Inhibitor Initiation and Dose Uptitration in Children With Cardiovascular Disease: A Retrospective Review of Standard Clinical Practice and a Prospective Randomized Clinical Trial. J Am Heart Assoc. 2016 May 20;5(5):e003230. doi: 10.1161/JAHA.116.003230.
PMID: 27207965DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Kantor, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 26, 2008
First Posted
August 27, 2008
Study Start
August 1, 2008
Primary Completion
August 1, 2009
Study Completion
December 1, 2009
Last Updated
August 27, 2008
Record last verified: 2008-08