Longterm Outcome After Ventricular Septal Defect Closure

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Brief Title

Longterm Outcome After Ventricular Septal Defect Closure

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Cardiac Output

Secondary Outcome

 Correlation

Condition

Ventricular Septal Defect

Intervention

MRI exercise test

Study Arms / Comparison Groups

 VSD-patients
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

March 2014

Completion Date

August 2016

Primary Completion Date

December 2015

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
      

Gender

All

Ages

18 Years - 25 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Vibeke E Hjortdal, Prof., DMSc, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT02138435

Organization ID

VSDBAA2014

Secondary IDs

2007-58-0010

Responsible Party

Sponsor

Study Sponsor

University of Aarhus


Study Sponsor

Vibeke E Hjortdal, Prof., DMSc, Principal Investigator, Aarhus University Hospital


Verification Date

September 2016