Rapid Versus Prolonged Inpatient Up-Titration of Captopril

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00742040
First received: August 26, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Heart Disease
Drug: Captopril
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

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

Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Captopril
A rapid 3-day up-titration protocol
Active Comparator: 2 Drug: Captopril
A slower 9-day up-titration protocol

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742040

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Paul Kantor, MD    (416)813-7239    paul.kantor@sickkids.ca   
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
Investigators
Principal Investigator: Paul Kantor, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Paul Kantor/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00742040     History of Changes
Other Study ID Numbers: 1000012229
Study First Received: August 26, 2008
Last Updated: August 26, 2008
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
up-titration
captopril
pediatric
cardiac patients

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Captopril
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014