PV Loop & Coarctation Study

Coarctation of Aorta Clinical Trial

Official title:

Assessment of the Impact of Transcatheter Stenting of Aortic Coarctation on the Left Ventricular Afterload and Work Using Left Ventricular Pressure Volume Loops

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362721
• Other study ID #: PEDS-2019-27404
• Status: Recruiting
• Start date: June 4, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Brittany Faanes
• Phone: 612-625-5929
• Email: grego318[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta

Intervention

Diagnostic Test:
• Pressure-volume loop catheter
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University of Texas-Southwestern	Dallas	Texas
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in left ventricular performance measured by ESPVR	The end systolic pressure volume relationship (ESPVR) summarizes ventricular systolic function and is measured as a slope of End systolic ventricular elastance (Ees) and volume-axis intercept Vo such that ESP = Ees (ESV-Vo) (ESP = end-systolic pressure, ESV = end-systolic volume, Vo represents the unstressed volume, which is the volume required to fill the ventricle before pressure rises). Shifts of the ESPVR occur with changes in ventricular contractility such that increases in contractility are associated with upward/leftward shifts of the ESPVR. ESPVR is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. It will be depicted as a continuous variable in mmHg/ml as well as graphically as a slope. Changes before and after intervention will be compared as shifts in ESPVR.	Immediately following intervention
Secondary	Change in left ventricular work as measured by Stroke Work	Stroke work (SW) is a continuous variable that measures the work done by the left ventricle in ejecting blood in one cardiac cycle. It is the area under one loop and is measured in mmHg.ml. SW is obtained by analysing the data and PV loops obtained by PV loop catheter in the left ventricle before and after intervention. SW before and after intervention will be compared as continuous variables using appropriate statistical tests.	Immediately following intervention
Secondary	Change in left ventricular efficiency as measured by ventricular arterial coupling	VA coupling is calculated by the ratio of effective arterial elastance (Ea), a measure of afterload, to LV endsystolic elastance (Ees), a relatively load independent measure of LV chamber performance. Both these measures are expressed in mmHg/ml and as continuous variables. Normal determined Ea and Ees values in resting subjects are 2.2 ± 0.8 mmHg/ml and 2.3 ± 1.0 mmHg/ml, respectively. When Ea/Ees ratio is approximately equal to 1.0, LV and arterial system are optimally coupled to produce stroke work, a measure of the efficiency of LV work, corresponding to the product of systolic arterial pressure and stroke volume, and related to oxygen consumption. When Ea/Ees ratio is <1.0, the stroke work remains close to optimal values, but when EA/EES ratio is >1.0, the stroke work significantly falls, and the LV becomes progressively less efficient. We will compare VA coupling before and after intervention and will be analyzed as continuous variables with appropriate statistical tests.	Immediately following intervention