Rapid Versus Prolonged Inpatient Up-Titration of Captopril

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742040

Enrollment

Registered

2008-08-27

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2008-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Keywords

up-titration, captopril, pediatric, cardiac patients

Brief summary

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

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.

Interventions

DRUGCaptopril

A rapid 3-day up-titration protocol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026