Coarctation of AortaLVOTONCT02545790
Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
An observational study of Coarctation of Aorta and Aortic Stenosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Coarctation of Aorta, Aortic Stenosis, Cardiac Hypertrophy
- What is being tested?
- Echocardiogram and Serology
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Potential subjects will be identified from the cardiac surgical and clinic schedules at Children's Hospital Colorado (CHCO).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Denver, Colorado, 80045
About this study
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
- Being tested
- Echocardiogram, Serology
- Keywords
- coarctation of aorta, aortic stenosis, biomarkers, cardiac hypertrophy
- Medical subject headings
- Aortic Coarctation, Aortic Valve Stenosis, Cardiomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramProcedure or surgery
Also called Diagnostics
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.
SerologyBiological
Also called Diagnostics
protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.
| Study group | Role | What they receive |
|---|---|---|
| Persistent hypertrophy | Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations. Receives: Procedure: Echocardiogram; Biological: Serology | |
| Normal geometry | Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations. Receives: Procedure: Echocardiogram; Biological: Serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular mass
Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction.
Measured: 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.
Measured: Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery
Secondary outcomes (6)
Relative wall thickness
A more detailed measure of relative wall thickness (RWT) will be assessed by echocardiography at 1 year after surgical correction.
Measured: 1 year after surgery
Left ventricular mass
Left ventricular mass will be measured by 3D echocardiography at 1 year after surgical correction.
Measured: 1 year after surgery
Change in relative wall thickness
Relative wall thickness will be measured by 2D echocardiography prior to surgery and at 1 year after surgical correction.
Measured: Within 1 week prior to surgery and 1 year after surgery
Change in relative wall thickness
Relative wall thickness will be measured by 2D echocardiography 24-72 hours and at 1 year after surgical correction.
Measured: 24-72 hours and 1 year after surgery
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.
Measured: 24-72 hours and 1 year after surgery
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.
Measured: Within 1 week prior to surgery and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of AortaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin S Frank, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545790
- Sponsor's protocol ID
- 15-0635
- Acronym
- LVOTO
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
- ClinicalTrials.gov ID
- NCT02545790
- Acronym / sponsor ID
- LVOTO / 15-0635
- Conditions
- Coarctation of Aorta, Aortic Stenosis, Cardiac Hypertrophy
- Keywords
- coarctation of aorta, aortic stenosis, biomarkers, cardiac hypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Persistent hypertrophy | – | Procedure: Echocardiogram, Biological: SerologyElevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations. |
| Normal geometry | – | Procedure: Echocardiogram, Biological: SerologyNormal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Potential subjects will be identified from the cardiac surgical and clinic schedules at Children's Hospital Colorado (CHCO).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramAlso: Diagnostics2 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. | Procedure or surgery | Normal geometry, Persistent hypertrophy |
| SerologyAlso: Diagnosticsprotein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs. | Biological | Normal geometry, Persistent hypertrophy |
Primary outcome
Left ventricular mass
Time frame: 1 year after surgery
Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction.
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.
6 secondary outcomes
Relative wall thickness
Time frame: 1 year after surgery
Left ventricular mass
Time frame: 1 year after surgery
Change in relative wall thickness
Time frame: 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
Change in left ventricular mass
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin S Frank, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coarctation of Aorta and Aortic Stenosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular mass (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.