Clinical trial NCT02545790: Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
Official title: Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coarctation of Aorta
Aortic Stenosis
Cardiac Hypertrophy
Keywords: coarctation of aorta
aortic stenosis
biomarkers
cardiac hypertrophy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 31
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Left ventricular mass
timeFrame: 1 year after surgery
measure: Change in left ventricular mass
timeFrame: Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery
Secondary outcomes:
measure: Relative wall thickness
timeFrame: 1 year after surgery
measure: Left ventricular mass
timeFrame: 1 year after surgery
measure: Change in relative wall thickness
timeFrame: Within 1 week prior to surgery and 1 year after surgery
measure: Change in relative wall thickness
timeFrame: 24-72 hours and 1 year after surgery
measure: Change in left ventricular mass
timeFrame: 24-72 hours and 1 year after surgery
measure: Change in left ventricular mass
timeFrame: Within 1 week prior to surgery and 1 year after surgery
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Benjamin S Frank, MD
role: PRINCIPAL_INVESTIGATOR
References: