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Rapid Versus Prolonged Inpatient Up-Titration of Captopril

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742040
Recruitment Status : Unknown
Verified August 2008 by The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : August 27, 2008
Last Update Posted : August 27, 2008
Information provided by:
The Hospital for Sick Children

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

Condition or disease Intervention/treatment Phase
Heart Disease Drug: Captopril Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Captopril

Arm Intervention/treatment
Experimental: 1 Drug: Captopril
A rapid 3-day up-titration protocol

Active Comparator: 2 Drug: Captopril
A slower 9-day up-titration protocol

Primary Outcome Measures :
  1. The number of patients reaching a target dose of 1mg/kg/dose (given three times a day). [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742040

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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Paul Kantor, MD    (416)813-7239   
Principal Investigator: Paul Kantor, MD         
Sub-Investigator: Lucy Roche, MD         
Sub-Investigator: Katherine Timberlake, MD         
Sub-Investigator: Brian McCrindle, MD         
Sub-Investigator: Mervin Balasingam         
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Paul Kantor, MD The Hospital for Sick Children
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Paul Kantor/Principal Investigator, The Hospital for Sick Children Identifier: NCT00742040    
Other Study ID Numbers: 1000012229
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: August 27, 2008
Last Verified: August 2008
Keywords provided by The Hospital for Sick Children:
cardiac patients
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents