Longterm Outcome After Ventricular Septal Defect Closure

NCT ID: NCT02138435

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-08-31

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.

Conditions

Ventricular Septal Defect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MRI exercise test

Intervention Type: OTHER

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

Gas-exchange exercise test

Intervention Type: OTHER

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.

MRI exercise test

Intervention Type: OTHER

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

Gas-exchange exercise test

Intervention Type: OTHER

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

Interventions

MRI exercise test

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

Intervention Type: OTHER

Gas-exchange exercise test

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vibeke E Hjortdal, Prof., DMSc

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Cardiothoracic surgery, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

References

Heiberg J, Laustsen S, Petersen AK, Hjortdal VE. Reduced long-term exercise capacity in young adults operated for ventricular septal defect. Cardiol Young. 2015 Feb;25(2):281-7. doi: 10.1017/S1047951113002084. Epub 2013 Nov 21.

Reference Type: BACKGROUND

PMID: 24565413 (View on PubMed)

Meijboom F, Szatmari A, Utens E, Deckers JW, Roelandt JR, Bos E, Hess J. Long-term follow-up after surgical closure of ventricular septal defect in infancy and childhood. J Am Coll Cardiol. 1994 Nov 1;24(5):1358-64. doi: 10.1016/0735-1097(94)90120-1.

Reference Type: BACKGROUND

PMID: 7930261 (View on PubMed)

Binkhorst M, van de Belt T, de Hoog M, van Dijk A, Schokking M, Hopman M. Exercise capacity and participation of children with a ventricular septal defect. Am J Cardiol. 2008 Oct 15;102(8):1079-84. doi: 10.1016/j.amjcard.2008.05.063. Epub 2008 Jul 26.

Reference Type: BACKGROUND

PMID: 18929713 (View on PubMed)

Reybrouck T, Rogers R, Weymans M, Dumoulin M, Vanhove M, Daenen W, Van der Hauwaert L, Gewillig M. Serial cardiorespiratory exercise testing in patients with congenital heart disease. Eur J Pediatr. 1995 Oct;154(10):801-6. doi: 10.1007/BF01959785.

Reference Type: BACKGROUND

PMID: 8529676 (View on PubMed)

Pedersen LM, Pedersen TA, Pedersen EM, Hojmyr H, Emmertsen K, Hjortdal VE. Blood flow measured by magnetic resonance imaging at rest and exercise after surgical bypass of aortic arch obstruction. Eur J Cardiothorac Surg. 2010 Mar;37(3):658-61. doi: 10.1016/j.ejcts.2009.07.041. Epub 2009 Sep 16.

Reference Type: BACKGROUND

PMID: 19762252 (View on PubMed)

Hjortdal VE, Christensen TD, Larsen SH, Emmertsen K, Pedersen EM. Caval blood flow during supine exercise in normal and Fontan patients. Ann Thorac Surg. 2008 Feb;85(2):599-603. doi: 10.1016/j.athoracsur.2007.08.062.

Reference Type: BACKGROUND

PMID: 18222273 (View on PubMed)

Other Identifiers

2007-58-0010

Identifier Type: OTHER

Identifier Source: secondary_id

1-10-72-7-14

Identifier Type: OTHER

Identifier Source: secondary_id

VSDBAA2014

Identifier Type: -

Identifier Source: org_study_id