Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions

Aortic Stenosis Clinical Trial

— LVOTO  

Official title:

Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02545790
• Other study ID #: 15-0635
• Status: Completed
• Start date: August 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Coarctation
• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiac Hypertrophy
• Cardiomegaly
• Coarctation of Aorta
• Hypertrophy

Intervention

Procedure:
• Echocardiogram
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.

Biological:
• Serology
protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

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