Ventricular Septal DefectNCT02138435
Longterm Outcome After Ventricular Septal Defect Closure
An observational study of Ventricular Septal Defect, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventricular Septal Defect
- What is being tested?
- MRI exercise test and Gas-exchange exercise test
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Patients: Surgical correction of VSD between 1990 and 1995
- Controls: 18-25 years old, with no medical records of heart disease
Who cannot join
- Missing journal
- Operation by ventriculotomy
- Other congenital anomalies
- Metallic implants or foreign objects
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic surgery, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Cardiac Output During Exercise in Young Adults Operated for Ventricular Septal Defect as Children
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.
Read more
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
- Being tested
- MRI exercise test, Gas-exchange exercise test
- Medical subject headings
- Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI exercise testOther
Measuring cardiac output with MRI during exercise on an ergometer bicycle.
Gas-exchange exercise testOther
Measuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI exercise test; Other: Gas-exchange exercise test | |
| 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. Receives: Other: MRI exercise test; Other: Gas-exchange exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
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.
Measured: 20 years after VSD surgery
Secondary outcomes (1)
Correlation
Correlation between MRI measured cardiac output and gas-exchange measured cardiac output.
Measured: 20 years after VSD surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ventricular Septal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibeke E Hjortdal, Prof., DMSc, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138435
- Sponsor's protocol ID
- VSDBAA2014
- Other IDs
- 2007-58-0010, 1-10-72-7-14
- Status last verified
- Sep 2016
- First submitted
- 1 May 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24565413Meijboom 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.
PubMed 7930261Binkhorst 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.
PubMed 18929713Reybrouck 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.
PubMed 8529676Pedersen 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.
PubMed 19762252Hjortdal 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.
PubMed 18222273
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Output During Exercise in Young Adults Operated for Ventricular Septal Defect as Children
- ClinicalTrials.gov ID
- NCT02138435
- Acronym / sponsor ID
- VSDBAA2014
- Conditions
- Ventricular Septal Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSD-patients | – | Other: MRI exercise test, Other: Gas-exchange exercise testPatients 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 | – | Other: MRI exercise test, Other: Gas-exchange exercise testA group of healthy control subjects. They will be tested by a MRI exercise test and a gas-exchange exercise test measuring cardiac output. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Patients: Surgical correction of VSD between 1990 and 1995
- Controls: 18-25 years old, with no medical records of heart disease
Key exclusion criteria (5 listed)
- Missing journal
- Operation by ventriculotomy
- Other congenital anomalies
- Metallic implants or foreign objects
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI exercise testMeasuring cardiac output with MRI during exercise on an ergometer bicycle. | Other | Control, VSD-patients |
| Gas-exchange exercise testMeasuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle. | Other | Control, VSD-patients |
Primary outcome
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.
1 secondary outcome
Correlation
Time frame: 20 years after VSD surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 24565413Heiberg 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.
- Background: PubMed 7930261Meijboom 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.
- Background: PubMed 18929713Binkhorst 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.
- Background: PubMed 8529676Reybrouck 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.
- Background: PubMed 19762252Pedersen 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.
- Background: PubMed 18222273Hjortdal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke E Hjortdal, Prof., DMSc principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Septal Defect, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: 20 years after VSD surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138435, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.