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

January 14, 2021 updated by: University of Colorado, Denver
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular mass
Time Frame: 1 year after surgery
Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction.
1 year after surgery
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.
Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after surgery
Left ventricular mass
Time Frame: 1 year after surgery
Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction.
1 year after surgery
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.
Within 1 week prior to surgery and 1 year after surgery
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.
24-72 hours and 1 year after surgery
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.
24-72 hours and 1 year after surgery
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.
Within 1 week prior to surgery and 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benjamin S Frank, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 8, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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