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PV Loop & Coarctation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05362721
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment
Coarctation of Aorta Diagnostic Test: Pressure-volume loop catheter

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : June 4, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pressure-volume loop catheter 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.




Primary Outcome Measures :
  1. Change in left ventricular afterload measured by arterial elastance [ Time Frame: Immediately following intervention ]

    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.



Secondary Outcome Measures :
  1. Change in left ventricular performance measured by ESPVR [ Time Frame: Immediately following intervention ]
    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.

  2. Change in left ventricular work as measured by Stroke Work [ Time Frame: Immediately following intervention ]
    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.

  3. Change in left ventricular efficiency as measured by ventricular arterial coupling [ Time Frame: Immediately following intervention ]
    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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for elective cardiac catheterization and stent therapy for coarctation
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362721


Contacts
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Contact: Brittany Faanes 612-625-5929 grego318@umn.edu

Locations
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United States, Massachusetts
Children's Hospital of Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ryan Callahan, MD    617-355-2079    ryan.callahan@cardio.chboston.org   
United States, Michigan
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Oliver Aregullin, MD    616-267-9150    oliver.aregullin@helendevoschidlrens.org   
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Brittany Faanes    612-625-5929    grego318@umn.edu   
Principal Investigator: Gurumurthy Hiremath, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Toby Rockefeller, MD       tarockefeller@cmh.edu   
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sarosh (Shawn) Batlivala, MD    513-636-4432    sarosh.batlivala@cchmc.org   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Gurumurthy Hiremath University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05362721    
Other Study ID Numbers: PEDS-2019-27404
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Coarctation of Aorta
COA
Additional relevant MeSH terms:
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Aortic Coarctation
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities