Rapid Versus Prolonged Inpatient Up-Titration of Captopril

Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00742040
• Other study ID #: 1000012229
• Status: Recruiting
• Phase: Phase 2
• First received: August 26, 2008
• Last updated: August 26, 2008
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease

Intervention

Drug:
• Captopril
A rapid 3-day up-titration protocol
• Captopril
A slower 9-day up-titration protocol

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients reaching a target dose of 1mg/kg/dose (given three times a day).		1 year	Yes