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CompletedNCT02545790LVOTOUpdated Jan 19, 2021

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

An observational study in Coarctation of Aorta, Aortic Stenosis and Cardiac Hypertrophy, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-01-19.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
31
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coarctation of Aorta
  • Aortic Stenosis
  • Cardiac Hypertrophy

Keywords

  • coarctation of aorta
  • aortic stenosis
  • biomarkers
  • cardiac hypertrophy
03

In context

Aortic Coarctation

51 studies on the registry are indexed under Aortic Coarctation; 15 are open to participants now.

This study's enrollment of 31 is below the median of 100 across 28 observational studies indexed under Aortic Coarctation.

Browse Aortic Coarctation studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Browse University of Colorado, Denver studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
31 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • ProcedureEchocardiogram

    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

  • BiologicalSerology

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

    Also known as: Diagnostics

06

What researchers measure

Primary outcomes

  1. Left ventricular mass

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

    Time frame: 1 year after surgery

  2. 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.

    Time frame: Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery

Secondary outcomes

  1. Relative wall thickness

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

    Time frame: 1 year after surgery

  2. Left ventricular mass

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

    Time frame: 1 year after surgery

  3. Change in relative wall thickness

    Relative wall thickness will be measured by 2D echocardiography prior to surgery and at 1 year after surgical correction.

    Time frame: Within 1 week prior to surgery and 1 year after surgery

  4. Change in relative wall thickness

    Relative wall thickness will be measured by 2D echocardiography 24-72 hours and at 1 year after surgical correction.

    Time frame: 24-72 hours and 1 year after surgery

  5. Change in left ventricular mass

    Change in left ventricular mass will be measured by 3D echocardiography 24-72 hours and 1 year after surgical correction.

    Time frame: 24-72 hours and 1 year after surgery

  6. Change in left ventricular mass

    Change in left ventricular mass will be measured by 3D echocardiography prior to surgery and at 1 year after surgical correction.

    Time frame: Within 1 week prior to surgery and 1 year after surgery

07

Study locations

1 site
  • Children's Hospital Colorado
    Denver, Colorado 80045, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2015 to primary completion in Dec 2017, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2015
First posted
Sep 10, 2015
StartActual
Aug 2015
Primary completionActual
Dec 2017
CompletionActual
Dec 31, 2020
Last update
Jan 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02545790
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Sep 10, 2015
Start date
Aug 2015
Primary completion
Dec 2017
Completion
Dec 31, 2020
Last update
Jan 19, 2021

Study contacts

Benjamin S Frank, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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