Bundle-Branch BlockNCT01480908
Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
A study testing Echocardiography at rest, Echocardiography during exercise and MRI at rest in people with Bundle-Branch Block and Heart Septal Defects, Ventricular, run by University of Aarhus at 1 site in Denmark.
Trial summary
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bundle-Branch Block, Heart Septal Defects, Ventricular
- What is being tested?
- Echocardiography at rest, Echocardiography during exercise and MRI at rest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2011to Dec 2014
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby
Who cannot join
- No chart to be found
- No EKG to be found
- Known bundle branch block prior to the surgery
- Other arrythmias
- Use of ventriculotomy
- Other disease than VSD
- Pacemaker or other metallic implants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects.
All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.
Read the detailed description
Right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. How this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown.
As a part of a PhD-study we therefore will try to illustrate this by echocardiography, MRI, exercise testing and other investigations 15 to 20 years after the surgical procedure. The study population thus consists of three different groups: 1. Patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. VSD-operated patients with right bundle branch block and 3. Healthy controls with no significant medical issues matched on age and sex. By carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. The perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. An additional perspective is to increase the awareness of protecting the bundle branch during the operation.
- Being tested
- Echocardiography at rest, Echocardiography during exercise, MRI at rest, Exercise testing
- Keywords
- Right bundle branch block, Ventricular septal defect, Echocardiography, MRI, Exercise testing
- Medical subject headings
- Bundle-Branch Block, Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography at restProcedure or surgery
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
Echocardiography during exerciseProcedure or surgery
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
MRI at restProcedure or surgery
Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.
Exercise testingProcedure or surgery
Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
| Study group | Role | What they receive |
|---|---|---|
| VSD, +Right bundle branch block | Experimental | Patients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients Receives: Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing |
| VSD, -Right bundle branch block | Experimental | Patients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients Receives: Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing |
| Control | Experimental | Healthy control subjects, about 20 patients Receives: Procedure: Echocardiography at rest; Procedure: Echocardiography during exercise; Procedure: MRI at rest; Procedure: Exercise testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic function at rest measured by echocardiography
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
Measured: All patients are tested only once about 20 years post to surgery
Secondary outcomes (5)
Maximal oxygen consumption during exercise
Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potentiel diffenrences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbondioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
Measured: All patients are tested only once about 20 years post to surgery
Force-frequency-relation during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
Measured: All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by MRI
Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.
Measured: All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by echocardiography
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
Measured: All patients are tested only once about 20 years post to surgery
Systolic function at rest measured by MRI
Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.
Measured: All patients are tested only once about 20 years post to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bundle-Branch BlockStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Responsible party
- Sponsor
- Investigators
- Vibeke Hjortdal, MD, DMSc, Prof., Study chair, Dept. of Cardiothoracic surgery, Aarhus Universitetshospital SkejbyMichael R. Schmidt, MD, PhD, Study director, Dept. of Cardiology, Aarhus University Hospital SkejbySteffen Ringgaard, Physics, PhD, Study director, Dept. MRI, Aarhus University Hospital SkejbyAndrew Redington, MD, DMSc, Prof., Study director, Dept. of Cardiology, The Hospital for Sick Children, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480908
- Sponsor's protocol ID
- VSDRBBBB-RV
- Status last verified
- Aug 2013
- First submitted
- 16 Nov 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT01480908
- Acronym / sponsor ID
- VSDRBBBB-RV
- Keywords
- Right bundle branch block, Ventricular septal defect, Echocardiography, MRI, Exercise testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby
- Study start
- Jun 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Nov 2011 (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.
The most common congenital heart disease is the ventricular septal defect, and after surgical closure of a such defect, an arrythmia called the right bundle branch block, is very frequent. Therefore the aim of this study is to investigate if this group of patients has inferior outcomes compared to the group without this arrythmia after surgical closure and compared to a group of healthy control subjects.
All patients will be undergoing 1. exercise testing, 2. echocardiography, 3. echocardiography during exercise, and 4. MRI. The perspective is the ability to point out a group of patients with a possible need of further intervention, and additionally to increase the awareness of protecting the electrical system of the heart during the operation.
Detailed description
Right bundle branch block is an exceedingly frequent complication in heart surgery, and especially in patients who have undergone surgical closure of a ventricular septal defect which is the most common congenital heart disease. How this bundle branch block effects the right ventricle of the heart on a long-term basis for this group of patients, is still unknown.
As a part of a PhD-study we therefore will try to illustrate this by echocardiography, MRI, exercise testing and other investigations 15 to 20 years after the surgical procedure. The study population thus consists of three different groups: 1. Patients whom undergone surgical closure of ventricular septal defect without postoperative right bundle branch block, 2. VSD-operated patients with right bundle branch block and 3. Healthy controls with no significant medical issues matched on age and sex. By carrying out the tests mentioned the right ventricles systolic function, diastolic function, the patients maximal exercise capacity and a lot of other parameters will be evaluated in the three groups of patients and compared amongst each other. The perspective therefore is the ability to point out a specific group of patients with an inferior outcome and with a possible need for further intervention. An additional perspective is to increase the awareness of protecting the bundle branch during the operation.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VSD, +Right bundle branch block | Experimental | Procedure: Echocardiography at rest, Procedure: Echocardiography during exercise, Procedure: MRI at rest, Procedure: Exercise testingPatients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients |
| VSD, -Right bundle branch block | Experimental | Procedure: Echocardiography at rest, Procedure: Echocardiography during exercise, Procedure: MRI at rest, Procedure: Exercise testingPatients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients |
| Control | Experimental | Procedure: Echocardiography at rest, Procedure: Echocardiography during exercise, Procedure: MRI at rest, Procedure: Exercise testingHealthy control subjects, about 20 patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby
Key exclusion criteria (8 listed)
- No chart to be found
- No EKG to be found
- Known bundle branch block prior to the surgery
- Other arrythmias
- Use of ventriculotomy
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 |
|---|---|---|
| Echocardiography at restDimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well. | Procedure or surgery | Control, VSD, +Right bundle branch block, VSD, -Right bundle branch block |
| Echocardiography during exerciseTASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation. | Procedure or surgery | Control, VSD, +Right bundle branch block, VSD, -Right bundle branch block |
| MRI at restDimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast. | Procedure or surgery | Control, VSD, +Right bundle branch block, VSD, -Right bundle branch block |
| Exercise testingMaximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test. | Procedure or surgery | Control, VSD, +Right bundle branch block, VSD, -Right bundle branch block |
Primary outcome
Systolic function at rest measured by echocardiography
Time frame: All patients are tested only once about 20 years post to surgery
Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspidale valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
5 secondary outcomes
Maximal oxygen consumption during exercise
Time frame: All patients are tested only once about 20 years post to surgery
Force-frequency-relation during exercise
Time frame: All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by MRI
Time frame: All patients are tested only once about 20 years post to surgery
Diastolic function at rest measured by echocardiography
Time frame: All patients are tested only once about 20 years post to surgery
Systolic function at rest measured by MRI
Time frame: All patients are tested only once about 20 years post to 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 3 Dec 2014.
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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 Hjortdal, MD, DMSc, Prof. study chair
Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby
Michael R. Schmidt, MD, PhD study director
Dept. of Cardiology, Aarhus University Hospital Skejby
Steffen Ringgaard, Physics, PhD study director
Dept. MRI, Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography at rest, Echocardiography during exercise and MRI at rest in people with Bundle-Branch Block and Heart Septal Defects, Ventricular, 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 1 inclusion and 8 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 3 Dec 2014. 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?
Systolic function at rest measured by echocardiography (time frame: All patients are tested only once about 20 years post to surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2014.