The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution
1 other identifier
interventional
12
1 country
1
Brief Summary
The primary objective of this study is to study the acute effects of angiotensin-converting enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional cavopulmonary connection (BCPC) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
December 18, 2015
CompletedDecember 18, 2015
November 1, 2015
1.5 years
August 25, 2008
July 26, 2013
November 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat
Baseline and after enalaprilat
Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat
Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat
Baseline and after enalaprilat
Study Arms (1)
Enalaprilat
EXPERIMENTALenalaprilat 0.005-0.01 mg/kg intravenous x 1 dose
Interventions
Enalaprilat will be administered intravenously i.v. 0.005 - 0.01 mg/kg i.v. over 1 minute
Eligibility Criteria
You may qualify if:
- BCPC patients at time of routine pre-Fontan catheterization
- Patients between the ages of 2 months and 5 years old
You may not qualify if:
- Patients who have had ACEI therapy within 24 hours of the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Kyong-Jin Lee
- Organization
- The Hospital for Sick Children
Study Officials
- PRINCIPAL INVESTIGATOR
Kyong-Jin Lee, MD
The Hospital for Sick Children
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Cardiologist
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
December 18, 2015
Results First Posted
December 18, 2015
Record last verified: 2015-11