Recruiting
Phase 2

Captopril

Sponsor:

The Hospital for Sick Children

Code:

NCT00742040

Conditions

Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Captopril

Captopril

Study Details

Brief summary:

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

Conditions

Heart Disease

Study ID

NCT00742040

Start date

Aug, 2008

Status verified date

Aug, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Aug, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

active comparator: 2

Interventions

Captopril

A rapid 3-day up-titration protocol

Captopril

A slower 9-day up-titration protocol

Primary outcome measure

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

Central Contacts and Locations

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Paul Kantor, MD

(416)813-7239paul.kantor@sickkids.ca

Principal Investigator:

Paul Kantor, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Aug 27, 2008

Last verified

Aug, 2008

Keywords

  • up-titration
  • captopril
  • pediatric
  • cardiac patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2008-08-27.