Rapid Versus Prolonged Inpatient Up-Titration of Captopril

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00742040
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Disease	Drug: Captopril; Drug: Captopril	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Rapid Versus Prolonged Inpatient Up-Titration of Captopril: A Randomized Clinical Trial
• Study Start Date: Aug 1, 2008
• Anticipated Primary Completion Date: Aug 1, 2009
• Anticipated Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Captopril; A rapid 3-day up-titration protocol
Active Comparator: 2	Drug: Captopril; A slower 9-day up-titration protocol

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada

Sponsors and Collaborators

• The Hospital for Sick Children

Investigators

• Principal Investigator: Paul Kantor, MD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00742040
• Other Study ID Numbers: 1000012229
• First Posted: Aug 27, 2008
• Last Update Posted: Aug 27, 2008
• Last Verified: Aug 1, 2008

• Keywords provided by , ,: up-titration; captopril; pediatric; cardiac patients
• Additional relevant MeSH terms: Heart Diseases; Captopril

Study Results

No Results Posted as of Aug 27, 2008