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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT02545790

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coarctation of Aorta Aortic Stenosis Cardiac Hypertrophy	Procedure: Echocardiogram Biological: Serology

Study Design

Study Type:

Observational

Actual Enrollment :

31 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Persistent hypertrophy Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.	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. Other Names: Diagnostics Biological: Serology protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs. Other Names: Diagnostics
Normal geometry Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.	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. Other Names: Diagnostics Biological: Serology protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs. Other Names: Diagnostics

Arm

Intervention/Treatment

Persistent hypertrophy

Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.

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.

Other Names:

Diagnostics

Biological: Serology

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

Other Names:

Diagnostics

Normal geometry

Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.

Procedure: Echocardiogram

Other Names:

Diagnostics

Biological: Serology

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

Other Names:

Diagnostics

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 relative wall thickness [24-72 hours and 1 year after surgery]
Relative wall thickness will be measured by 2D echocardiography 24-72 hours 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.
Change in left ventricular mass [Within 1 week prior to surgery and 1 year after surgery]
Change in left ventricular mass will be measured by 3D echocardiography prior to surgery and at 1 year after surgical correction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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