Rapid Versus Prolonged Inpatient Up-Titration of Captopril

August 26, 2008 updated by: The Hospital for Sick Children

Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • The Hospital for Sick Children
        • Contact:
        • Principal Investigator:
          • Paul Kantor, MD
        • Sub-Investigator:
          • Lucy Roche, MD
        • Sub-Investigator:
          • Katherine Timberlake, MD
        • Sub-Investigator:
          • Brian McCrindle, MD
        • Sub-Investigator:
          • Mervin Balasingam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Captopril
A rapid 3-day up-titration protocol
Drug: Captopril
A slower 9-day up-titration protocol
Active Comparator: 2
Drug: Captopril
A rapid 3-day up-titration protocol
Drug: Captopril
A slower 9-day up-titration protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Paul Kantor, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

August 27, 2008

Last Update Submitted That Met QC Criteria

August 26, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000012229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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