Rapid Versus Prolonged Inpatient Up-Titration of Captopril

NCT ID: NCT00742040

Last Updated: 2008-08-27

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.

Detailed Description

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Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed pediatric cardiac medication and overall their safety in children is widely accepted. Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0.1 mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges are quoted for maintenance doses and no guidance is given as to the best method of up-titration, The physician is left uncertain of the optimal dose and how best to achieve it.

The ultimate goal of this study is to be in a position to provide physicians caring for children with heart disease information about how to safely up-titrate this widely used medication, and by doing so to improve dosing in the wider pediatric population.

Conditions

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Heart Disease

Keywords

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up-titration captopril pediatric cardiac patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Captopril

Intervention Type DRUG

A rapid 3-day up-titration protocol

2

Group Type ACTIVE_COMPARATOR

Captopril

Intervention Type DRUG

A slower 9-day up-titration protocol

Interventions

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Captopril

A rapid 3-day up-titration protocol

Intervention Type DRUG

Captopril

A slower 9-day up-titration protocol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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The Hospital for Sick Children

Principal Investigators

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Paul Kantor, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Paul Kantor, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 27207965 (View on PubMed)

Other Identifiers

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1000012229

Identifier Type: -

Identifier Source: org_study_id