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Longterm Outcome After Ventricular Septal Defect Closure

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ClinicalTrials.gov Identifier: NCT02138435
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Isolated ventricular septal defect (VSD) is a well know congenital heart anomaly. If discovered in infancy or early childhood surgical intervention can be of necessity depending on the size of the defect, to assure a healthy adulthood. The long-term results of surgical closure of VSD in childhood are good and after surgery the children are considered as equally healthy and physically fit as their peers. However, there is inconsistency in data regarding follow-up on this group of patients, in relation to exercise capacity as a measure of the cardiopulmonary function. To further approach this matter the post-operative cardiac factors of these patients have to be investigated.

With this study the investigators intend to examine the long-term outcome on cardiac output after heart surgery in VSD-patients. It presents an opportunity to also evaluate the correlation between cardiac output determined by gas-exchange and by MRI. The overall objectives of this study are to 1) examine whether VSD-operated patients have reduced cardiac output during exercise in comparison with matched controls, and furthermore 2) to evaluate a correlation between cardiac output measured by MRI and cardiac output determined by gas-exchange.

The project is designed as a long-term follow-up and method study. A cohort of 20 children who in the 1990's underwent surgical closure of a congenital VSD will be asked to participate in this study. An equal amount of healthy young adults, will function as control group. Each participant will complete two different exercise tests, a MRI of the heart during lower body exercise on a supine ergometer bicycle, and a Supine ergometer bicycle exercise test. This data can be used for comparing cardiac output between the test groups, and furthermore it allows an evaluation of the correlation between the two methods.

VSD is as described, the most common congenital heart anomaly. If not intervened with in childhood, it can cause severe heart complications later in life. It is unclear whether this intervention can cause long-term impact on patients exercise capacity, and for that reason it is of great importance that we strive for improving our knowledge of the long-term postsurgical outcome after VSD-closure.


Condition or disease Intervention/treatment
Ventricular Septal Defect Other: MRI exercise test Other: Gas-exchange exercise test

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiac Output During Exercise in Young Adults Operated for Ventricular Septal Defect as Children
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
VSD-patients
Patients who had VSD closure between 1990 and 1995. They will be tested by a MRI exercise test and a gas-exchange exercise test measuring cardiac output.
Other: MRI exercise test
Measuring cardiac output with MRI during exercise on an ergometer bicycle.

Other: Gas-exchange exercise test
Measuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle.

Control
A group of healthy control subjects. They will be tested by a MRI exercise test and a gas-exchange exercise test measuring cardiac output.
Other: MRI exercise test
Measuring cardiac output with MRI during exercise on an ergometer bicycle.

Other: Gas-exchange exercise test
Measuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle.




Primary Outcome Measures :
  1. Cardiac Output [ Time Frame: 20 years after VSD surgery ]

    MRI measured: From obtained standard scout images of the heart and great vessels, flow measurement planes will be planned orthogonally to the ascending aorta and the pulmonary artery. MRI real-time flow will then be measured at different exercise levels orthogonally to the ascending aorta and pulmonary artery just above the level of the valves. Ascending aortic and pulmonary artery blood flow will be used to measure cardiac output in post-MRI analysis.

    Gas-exchange measured: Using a supine ergometer cycle, the pulmonary ventilation and gas exchange will be measured breath-by-breath. End points are peak oxygen uptake, stroke volume, and cardiac output. Fick's principle will be used for estimating cardiac output.



Secondary Outcome Measures :
  1. Correlation [ Time Frame: 20 years after VSD surgery ]
    Correlation between MRI measured cardiac output and gas-exchange measured cardiac output.



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Of 182 children who in the years 1990 to 1995 underwent surgical closure of a congenital VSD at Aarhus University Hospital (AUH), Denmark, a small group of 20 is randomly selected to participate. These children form a homogenous group of patients comparing surgeons, anesthetists, surgical procedures and post-surgical period. An equal amount of healthy controls, matched on age and gender, form the control group.
Criteria

Inclusion Criteria:

  • Patients: Surgical correction of VSD between 1990 and 1995
  • Controls: 18-25 years old, with no medical records of heart disease

Exclusion Criteria:

  • Missing journal
  • Operation by ventriculotomy
  • Other congenital anomalies
  • Metallic implants or foreign objects
  • Pregnancy

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): NCT02138435


Locations
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Denmark
Department of Cardiothoracic surgery, Aarhus University Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Vibeke E Hjortdal, Prof., DMSc Aarhus University Hospital
Publications:
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02138435    
Other Study ID Numbers: VSDBAA2014
2007-58-0010 ( Other Identifier: The Danish Data Protection Agency )
1-10-72-7-14 ( Other Identifier: The Regional Committee on Biomedical Research Ethics )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities