Skip to main content
OpenTrials
Completed

NCT Number: NCT02545790

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coarctation of Aorta Aortic Coarctation Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiac Hypertrophy Cardiomegaly Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Diagnostics

Serology

Biological

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

Other names: Diagnostics

Primary outcomes

  1. Left ventricular mass

    Time frame: 1 year after surgery

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

  2. Change in left ventricular mass

    Time frame: 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 outcomes

  1. Relative wall thickness

    Time frame: 1 year after surgery

    A more detailed measure of relative wall thickness (RWT) will be assessed by echocardiography at 1 year after surgical correction.

  2. Left ventricular mass

    Time frame: 1 year after surgery

    Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction.

  3. Change in relative wall thickness

    Time frame: 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.

  4. Change in relative wall thickness

    Time frame: 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.

  5. Change in left ventricular mass

    Time frame: 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.

  6. Change in left ventricular mass

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: LVOTO

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Sep 10, 2015
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.