- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545790
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
Status
Completed
Intervention / Treatment
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
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-
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:
protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.
Other Names:
|
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:
protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.
Other Names:
|
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.
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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
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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.
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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
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A more detailed measure of relative wall thickness (RWT) will be assessed by echocardiography at 1 year after surgical correction.
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1 year after surgery
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Left ventricular mass
Time Frame: 1 year after surgery
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Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction.
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1 year after surgery
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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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-0635
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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