Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113087
Status:
COMPLETED
Last Update Posted:
2010-09-28
First Post:
2005-06-03
Brief Title:
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
Trial of ACE Inhibition in Infants With Single Ventricle A Trial Conducted by the Pediatric Heart Network
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISV
Brief Summary:
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor ACE-I enalapril to infants with a functional single ventricle The study will also compare the effect of ACE-I therapy to placebo on somatic growth and compare the effect of ACE-I therapy to placebo on signs and symptoms of heart failure neurodevelopmental and functional status ventricular geometry function and atrioventricular AV valve regurgitation In addition the study will determine the relationship between genetic polymorphisms linked to ventricular hypertrophy enlarged heart and the response to ACE-I therapy and compare the incidence of adverse events in subjects treated with ACE-I with those in subjects treated with placebo
Detailed Description:
BACKGROUND
Growth impairment is common in infants and children with congenital heart disease most often in the presence of congestive heart failure andor cyanosis Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surgery Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known ACE-Is are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth The ability of an ACE-I to improve somatic growth in infants with a single ventricle has not been previously studied
This study has been approved by the Institutional Review BoardsResearch Ethics Boards of all participating clinical centers
Hospital for Sick Children Toronto Canada
Childrens Hospital Boston Boston MA
Columbia College of Physicians and Surgeons New York NY
Childrens Hospital of Philadelphia Philadelphia PA
Duke University Medical Center Durham NC
Brody School of Medicine at East Carolina University Greenville NC
Wake Forest Baptist Medical Center Winston Salem NC
Medical University of South Carolina Charleston SC
Primary Childrens Medical Center Salt Lake City UT
Childrens Hospital of Wisconsin Milwaukee WI
Cincinnati Childrens Hospital Medical Center Cincinnati OH
DESIGN NARRATIVE
This is a prospective randomized double-blind placebo-controlled trial of ACE-I in infants with a single ventricle After stratification by ventricular anatomy neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 months
Growth impairment is common in infants and children with congenital heart disease most often in the presence of congestive heart failure andor cyanosis Growth failure is noted in many infants with a single ventricle who manifest both cyanosis and heart failure that commonly persist after palliative surgery Whether this impairment is related to persistent or progressive abnormalities in cardiac structure and function is not known ACE-Is are widely used in the treatment of infants with severe congestive heart failure to improve cardiac function and somatic growth The ability of an ACE-I to improve somatic growth in infants with a single ventricle has not been previously studied
This study has been approved by the Institutional Review BoardsResearch Ethics Boards of all participating clinical centers
Hospital for Sick Children Toronto Canada
Childrens Hospital Boston Boston MA
Columbia College of Physicians and Surgeons New York NY
Childrens Hospital of Philadelphia Philadelphia PA
Duke University Medical Center Durham NC
Brody School of Medicine at East Carolina University Greenville NC
Wake Forest Baptist Medical Center Winston Salem NC
Medical University of South Carolina Charleston SC
Primary Childrens Medical Center Salt Lake City UT
Childrens Hospital of Wisconsin Milwaukee WI
Cincinnati Childrens Hospital Medical Center Cincinnati OH
DESIGN NARRATIVE
This is a prospective randomized double-blind placebo-controlled trial of ACE-I in infants with a single ventricle After stratification by ventricular anatomy neonates will be randomly assigned to receive enalapril or placebo and then followed for 14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068269 | NIH | None | httpsreporternihgovquickSearchU01HL068269 |
| U01HL068270 | NIH | None | None |
| U01HL068279 | NIH | None | None |
| U01HL068281 | NIH | None | None |
| U01HL068285 | NIH | None | None |
| U01HL068288 | NIH | None | None |
| U01HL068290 | NIH | None | None |
| U01HL068292 | NIH | None | None |