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

Completed

• Conditions: Coarctation of Aorta; Aortic Stenosis; Cardiac Hypertrophy
• Interventions: Procedure: Echocardiogram; Biological: Serology

• Registration Number: NCT02545790
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-08
• Study First Posted: 2015-09-10
• Primary Completion: 2017-12
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Persistent hypertrophy	Serology	Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Persistent hypertrophy	Echocardiogram	Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Normal geometry	Echocardiogram	Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Normal geometry	Serology	Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Denver, Colorado, United States