Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308230
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2006-03-27
Brief Title:
Pilot Study of B-Type Natrieutic Peptide BNP Levels in Patients With Congenital Heart DiseaseBNP
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Pilot Study of B-Type Natriuretic Peptide BNP Levels in Patients With Congenital Heart Disease and Systemic Right Ventricles or Volume Overloaded Pulmonic Right Ventricles
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
The object of this study is to measure the levels of B-type Natriuretic Peptide BNP in patients with congenital heart disease normal individuals and patients with acquired heart failure and compare the results from each group
Detailed Description:
Enrollment Patients with congenital heart disease seen at Emory Clinics Adult Congenital Heart Disease program Crawford Long Hospital will be asked to participate in this pilot study Sample size 20 patients 5 in each group Screening Phase Demographic data medical history physical examination including vital signs and room air oxygen saturation and medications will be recorded New York Heart association functional class will be recorded
BNP Levels Approximately 7 cc of blood will be collected The blood will be analyzed for B-type natriuretic peptide on a rapid assay in the clinic
Exercise Tolerance will be measured by a 6 minute walk test on day of visit Echocardiogram A complete echocardiogram including assessment of anatomy ventricular function and valvular function will be performed following the phlebotomy
Quality of life The minnesota living with heart failure questionnaire will be administered on the day of collection of neurohormonal levels A research nurse will be available to assist the patient if needed
BNP Levels Approximately 7 cc of blood will be collected The blood will be analyzed for B-type natriuretic peptide on a rapid assay in the clinic
Exercise Tolerance will be measured by a 6 minute walk test on day of visit Echocardiogram A complete echocardiogram including assessment of anatomy ventricular function and valvular function will be performed following the phlebotomy
Quality of life The minnesota living with heart failure questionnaire will be administered on the day of collection of neurohormonal levels A research nurse will be available to assist the patient if needed
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