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

NCT02545790 | Completed

• 1 other identifier: 15-0635
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Coarctation of Aorta; Aortic Stenosis; Cardiac Hypertrophy

Keywords

coarctation of aorta; aortic stenosis; biomarkers; cardiac hypertrophy

Outcome Measures

Primary Outcomes (2)

• Left ventricular mass

  Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction.

  1 year after surgery

• 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 Outcomes (6)

• Relative wall thickness

  1 year after surgery

• Left ventricular mass

  1 year after surgery

• Change in relative wall thickness

  Within 1 week prior to surgery and 1 year after surgery

• Change in relative wall thickness

  24-72 hours and 1 year after surgery

• Change in left ventricular mass

  24-72 hours and 1 year after surgery

Study Arms (2)

Persistent hypertrophy

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

Procedure: Echocardiogram; Biological: Serology

Normal geometry

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

Procedure: Echocardiogram; Biological: Serology

Interventions

Echocardiogram PROCEDURE

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.

Also known as: Diagnostics

Normal geometry; Persistent hypertrophy

Serology BIOLOGICAL

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

Also known as: Diagnostics

Normal geometry; Persistent hypertrophy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be identified from the cardiac surgical and clinic schedules at Children's Hospital Colorado (CHCO).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and tissue samples from patients will be stored for the duration of the study. Patients may choose to consent to have these samples stores beyond the completion of primary analysis for testing in future studies.

MeSH Terms

Conditions

Aortic Coarctation; Aortic Valve Stenosis; Cardiomegaly

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Benjamin S Frank, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 10, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Locations

US (1)