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

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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

45

Start Date

August 2015

Completion Date

December 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

June 2020