Longterm Outcome After Ventricular Septal Defect Closure

Completed

• Conditions: Ventricular Septal Defect
• Interventions: Other: MRI exercise test; Other: Gas-exchange exercise test

• Registration Number: NCT02138435
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Primary Completion: 2015-12
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VSD-patients	MRI exercise test	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.
Control	Gas-exchange exercise test	A group of healthy control subjects. They will be tested by a MRI exercise test and a gas-exchange exercise test measuring cardiac output.
VSD-patients	Gas-exchange exercise test	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.
Control	MRI exercise test	A group of healthy control subjects. They will be tested by a MRI exercise test and a gas-exchange exercise test measuring cardiac output.

Primary Outcome Measures

Name	Time	Method
Cardiac Output	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

Name	Time	Method
Correlation	20 years after VSD surgery	Correlation between MRI measured cardiac output and gas-exchange measured cardiac output.

Trial Locations

Locations (1)

Department of Cardiothoracic surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark