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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Cardiac Hypertrophy
Aortic Stenosis
Coarctation of Aorta

Treatments

Procedure: Echocardiogram
Biological: Serology

Study type

Observational

Funder types

Other

Identifiers

NCT02545790
15-0635

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

31 participants in 2 patient groups

Persistent hypertrophy
Description:
Elevated cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Treatment:
Biological: Serology
Procedure: Echocardiogram
Normal geometry
Description:
Normal cardiac mass at follow-up time point as measured by Echocardiographic and Serologic evaluations.
Treatment:
Biological: Serology
Procedure: Echocardiogram

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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