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Rapid Versus Prolonged Inpatient Up-Titration of Captopril

T

The Hospital for Sick Children

Status and phase

Unknown
Phase 2

Conditions

Heart Disease

Treatments

Drug: Captopril

Study type

Interventional

Funder types

Other

Identifiers

NCT00742040
1000012229

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Captopril
Drug: Captopril
2
Active Comparator group
Treatment:
Drug: Captopril
Drug: Captopril

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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