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Completed

NCT Number: NCT02138435

Longterm Outcome After Ventricular Septal Defect Closure

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiothoracic surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI exercise test

Other

Measuring cardiac output with MRI during exercise on an ergometer bicycle.

Gas-exchange exercise test

Other

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

Primary outcomes

  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 outcomes

  1. Correlation

    Time frame: 20 years after VSD surgery

    Correlation between MRI measured cardiac output and gas-exchange measured cardiac output.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Cardiac Output During Exercise in Young Adults Operated for Ventricular Septal Defect as Children

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
May 14, 2014
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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