Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113698
Status:
TERMINATED
Last Update Posted:
2014-03-13
First Post:
2005-06-09
Brief Title:
Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lower than expected enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AceiMR
Brief Summary:
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition ACE-I therapy for the treatment of mitral regurgitation MR
Detailed Description:
BACKGROUND
MR causes volume overload and hemodynamic burden on the left ventricle Initial compensatory mechanisms may fail leading to increased severity Patients who have had repair of an atrioventricular septal defect AVSD are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic contributing to the likelihood that they might respond to medical therapy
DESIGN NARRATIVE
This is a randomized double-blind placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD who were then evaluated at 6 months for trial eligibility
MR causes volume overload and hemodynamic burden on the left ventricle Initial compensatory mechanisms may fail leading to increased severity Patients who have had repair of an atrioventricular septal defect AVSD are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic contributing to the likelihood that they might respond to medical therapy
DESIGN NARRATIVE
This is a randomized double-blind placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD who were then evaluated at 6 months for trial eligibility
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 | None |
| 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 | httpsreporternihgovquickSearchU01HL068292 |