PV Loop & Coarctation Study

NCT05362721 | Active Not Recruiting

• 1 other identifier: PEDS-2019-27404
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 7

Brief Summary

Coarctation of the aorta accounts for 4-7% of all congenital heart disease. While stent therapy, when feasible, is the standard of care for coarctation, it may not completely improve the work (and afterload) of the heart due to its effects on the elasticity of the aorta. This study will provide the information needed to understand the effects of current management on the cardiac mechanics and work.

Conditions

Coarctation of Aorta

Keywords

Coarctation of Aorta; COA

Outcome Measures

Primary Outcomes (1)

• Change in left ventricular afterload measured by arterial elastance

  Arterial elastance (Ea) is measured by the pressure volume (PV) loop catheter in the left ventricle. The PV loop catheter measures pressure and volume simultaneously during the entire cardiac cycle. Arterial elastance is a measure of ventricular afterload and will be calculated using previously described formula; Ea (arterial elastance): Ea = Pend systole/ SV (where P, is pressure at end systole, and SV is stroke volume). Elastance will be reported as a continuous variable in mmHg/mL with a higher number indicating an increase in elastance and a negative number indicating a decrease in elastance. Change in elastance before and after stent placement will be compared using paired T test.

  Immediately following intervention

Secondary Outcomes (3)

• Change in left ventricular performance measured by ESPVR

  Immediately following intervention

• Change in left ventricular work as measured by Stroke Work

  Immediately following intervention

• Change in left ventricular efficiency as measured by ventricular arterial coupling

  Immediately following intervention

Study Arms (1)

Pressure-volume loop catheter

Diagnostic Test: Pressure-volume loop catheter

Interventions

Pressure-volume loop catheter DIAGNOSTIC_TEST

The cardiac catheterization procedure will be done according to standard protocol as part of the standard clinical care. This has become the standard of care in any patient in which it feasible and is performed with low risk.

Pressure-volume loop catheter

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred for elective cardiac catheterization and stent therapy for coarctation

You may qualify if:

• Children 6 years of age and older and adults of all races and both sexes referred for elective cardiac catheterization and stent therapy for coarctation
• Those who provide informed consent for study participant.

You may not qualify if:

• Children who undergo other interventions in addition to the coarctation
• Children with single ventricle physiology.
• Renal impairment
• Participant unwilling to sign a consent form.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (7)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

University of Texas-Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Aortic Coarctation

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gurumurthy Hiremath

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 5, 2022
• Study Start: June 4, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (7)