Brief Title
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
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.
Study Type
Observational
Primary Outcome
Left ventricular mass
Secondary Outcome
Relative wall thickness
Condition
Coarctation of Aorta
Intervention
Echocardiogram
Study Arms / Comparison Groups
Persistent hypertrophy
Description: Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
31
Start Date
August 2015
Completion Date
December 31, 2020
Primary Completion Date
December 2017
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
Gender
All
Ages
N/A - 18 Years
Accepts Healthy Volunteers
No
Contacts
Benjamin S Frank, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02545790
Organization ID
15-0635
Responsible Party
Sponsor
Study Sponsor
University of Colorado, Denver
Study Sponsor
Benjamin S Frank, MD, Principal Investigator, University of Colorado, Denver
Verification Date
January 2021