Coarctation of Aorta, Aortic Stenosis, Cardiac Hypertrophy
Conditions
Keywords
coarctation of aorta, aortic stenosis, biomarkers, cardiac hypertrophy
Brief summary
This study is designed to learn more about children who have blockage of the left side of their heart. The goal is to determine how much the heart muscle has thickened before surgery and how it changes in the months after surgery. Investigators are also looking for blood tests that may help them predict which patients will have the most thickening pre-operatively and the best return towards normal after surgery. The findings of this study will help the investigators develop new tests to monitor affected patients and develop new therapies to help minimize heart thickening.
Interventions
PROCEDUREEchocardiogram
2 and 3-dimensional echocardiographic images will be obtained to estimate LV mass, ejection fraction (Simpson's biplane), fractional shortening (M mode Doppler), and pulse-wave estimated pressure gradient across the outflow obstruction.
BIOLOGICALSerology
protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.
Sponsors
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Congenital heart disease patients with the following diagnoses undergoing surgical repair: Coarctation of the aorta (CoA), aortic stenosis (AS), subaortic membrane (sub-AS), supravalvar aortic stenosis (supra-AS). * All patients will have age from birth through 18 years of age. * While we will generally not enroll patients with other co-morbid heart disease that would alter the cardiac physiology (see
Exclusion criteria
), patients with patent foramen ovale, atrial septal defect, and patent ductus arteriosus specifically will be allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular mass | 1 year after surgery | Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction. |
| Change in left ventricular mass | Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery | Left ventricular mass will be measured by 2D echocardiography prior to surgery, immediately after surgery, and will be compared to that measured at 1 year after surgical correction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative wall thickness | 1 year after surgery | A more detailed measure of relative wall thickness (RWT) will be assessed by echocardiography at 1 year after surgical correction. |
| Left ventricular mass | 1 year after surgery | Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction. |
| Change in relative wall thickness | Within 1 week prior to surgery and 1 year after surgery | Relative wall thickness will be measured by 2D echocardiography prior to surgery and at 1 year after surgical correction. |
| Change in left ventricular mass | 24-72 hours and 1 year after surgery | Change in left ventricular mass will be measured by 3D echocardiography 24-72 hours and 1 year after surgical correction. |
Countries
United States
Outcome results
None listed