Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123071
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2005-07-20
Brief Title:
Variability of Ventricular Mass Volume Ejection Fraction in Pediatric Cardiomyopathy Patients-Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Variability of Ventricular Mass Volume and Ejection Fraction in Pediatric Cardiomyopathy Patients A Study Conducted by the Pediatric Heart Network
Status:
COMPLETED
Status Verified Date:
2013-01
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:
VVV
Brief Summary:
This observational study will provide data variations in ventricular size and function that are essential to designing and conducting clinical trials In addition the study will evaluate intra- and inter-study variability seen in echocardiography
Detailed Description:
BACKGROUND
Cardiomyopathy is an important cause of chronic disability and death in pediatric patients and currently accounts for approximately 50 of cardiac transplants performed during childhood Left ventricular LV size and function are important independent predictors of outcome and echocardiography is the primary way to assess ventricular function in children Although there is extensive experience with this technology data are limited on how ventricular function changes over time in children which is a major impediment to conducting controlled trials of therapy in children
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
Washington University St Louis MO
DESIGN NARRATIVE
This observational study will prospectively evaluate pediatric patients with dilated cardiomyopathy who are undergoing clinically indicated echocardiographic evaluation of LV function Patients who undergo at least two echocardiograms 3 to 18 months apart will have their studies performed by the same ultrasonographer All studies will be sent to the core laboratory for evaluation of variability in LV mass volume and ejection fraction
Cardiomyopathy is an important cause of chronic disability and death in pediatric patients and currently accounts for approximately 50 of cardiac transplants performed during childhood Left ventricular LV size and function are important independent predictors of outcome and echocardiography is the primary way to assess ventricular function in children Although there is extensive experience with this technology data are limited on how ventricular function changes over time in children which is a major impediment to conducting controlled trials of therapy in children
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
Washington University St Louis MO
DESIGN NARRATIVE
This observational study will prospectively evaluate pediatric patients with dilated cardiomyopathy who are undergoing clinically indicated echocardiographic evaluation of LV function Patients who undergo at least two echocardiograms 3 to 18 months apart will have their studies performed by the same ultrasonographer All studies will be sent to the core laboratory for evaluation of variability in LV mass volume and ejection fraction
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 |
|---|---|---|---|
| U01HL068292 | NIH | None | None |
| U01HL068290 | NIH | None | None |
| U01HL068288 | NIH | None | None |
| U01HL068285 | NIH | None | None |
| U01HL068281 | NIH | None | None |
| U01HL068279 | NIH | None | None |
| U01HL068270 | NIH | None | None |
| U42 HL068269 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01HL068270 |