Aortic Stenosis Clinical Trial
— LVOTOOfficial title:
Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
NCT number | NCT02545790 |
Other study ID # | 15-0635 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2015 |
Est. completion date | December 31, 2020 |
Verified date | January 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. Exclusion Criteria: - Patients with lesions not listed in inclusion criteria (including but not limited to hypoplastic left heart syndrome, Shone's complex, mitral valve stenosis or regurgitation greater than trivial, non-restrictive ventricular septal defect, interrupted aortic arch, atrio-ventricular canal defect) - Corrected gestational age at time of surgery <34 weeks - Weight at time of surgery <2000g. - Patients who will not be seen for any follow-up care at Children's Hospital Colorado |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left ventricular mass | Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction. | 1 year after surgery | |
Primary | Change in left ventricular mass | 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. | Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery | |
Secondary | Relative wall thickness | A more detailed measure of relative wall thickness (RWT) will be assessed by echocardiography at 1 year after surgical correction. | 1 year after surgery | |
Secondary | Left ventricular mass | Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction. | 1 year after surgery | |
Secondary | Change in relative wall thickness | Relative wall thickness will be measured by 2D echocardiography prior to surgery and at 1 year after surgical correction. | Within 1 week prior to surgery and 1 year after surgery | |
Secondary | Change in relative wall thickness | Relative wall thickness will be measured by 2D echocardiography 24-72 hours and at 1 year after surgical correction. | 24-72 hours and 1 year after surgery | |
Secondary | Change in left ventricular mass | Change in left ventricular mass will be measured by 3D echocardiography 24-72 hours and 1 year after surgical correction. | 24-72 hours and 1 year after surgery | |
Secondary | Change in left ventricular mass | Change in left ventricular mass will be measured by 3D echocardiography prior to surgery and at 1 year after surgical correction. | Within 1 week prior to surgery and 1 year after surgery |
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