Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Bundle-Branch Block Heart Septal Defects, Ventricular |
Procedure: Echocardiography at rest Procedure: Echocardiography during exercise Procedure: MRI at rest Procedure: Exercise testing |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect |
- Systolic function at rest measured by echocardiography [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]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.
- Maximal oxygen consumption during exercise [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]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.
- Force-frequency-relation during exercise [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
- Diastolic function at rest measured by MRI [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]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.
- Diastolic function at rest measured by echocardiography [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]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.
- Systolic function at rest measured by MRI [ Time Frame: All patients are tested only once about 20 years post to surgery ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: VSD, +Right bundle branch block
Patients undergone surgical closure of ventricular septal defect and have a postoperative right bundle branch block, about 20 patients
|
Procedure: Echocardiography at rest
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.
Procedure: Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
Procedure: MRI at rest
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.
Procedure: Exercise testing
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.
|
|
Experimental: VSD, -Right bundle branch block
Patients undergone surgical closure of ventricular septal defect and does not have a postoperative right bundle branch block, about 20 patients
|
Procedure: Echocardiography at rest
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.
Procedure: Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
Procedure: MRI at rest
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.
Procedure: Exercise testing
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.
|
|
Experimental: Control
Healthy control subjects, about 20 patients
|
Procedure: Echocardiography at rest
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.
Procedure: Echocardiography during exercise
TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
Procedure: MRI at rest
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.
Procedure: Exercise testing
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Operated for VSD in the period from 1990 to 1995 on Aarhus University Hospital Skejby
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Johan Heiberg, MD, PhD. student | +45 78453083 | johan.heiberg@ki.au.dk |
| Contact: Vibeke E. Hjortdal, DM, DMSc, professor | +45 7845 3014 | vibehjor@rm.dk |
| Denmark | |
| Aarhus University Hospital Skejby | Recruiting |
| Aarhus, Aarhus N, Denmark, 8200 | |
| Contact: Johan Heiberg, MD, PhD. student +45 78453083 johan.heiberg@ki.au.dk | |
| Principal Investigator: Johan Heiberg, MD, Ph.D. student | |
| Study Chair: | Vibeke Hjortdal, MD, DMSc, Prof. | Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby |
| Study Director: | Michael R. Schmidt, MD, PhD | Dept. of Cardiology, Aarhus University Hospital Skejby |
| Study Director: | Steffen Ringgaard, Physics, PhD | Dept. MRI, Aarhus University Hospital Skejby |
| Study Director: | Andrew Redington, MD, DMSc, Prof. | Dept. of Cardiology, The Hospital for Sick Children, Toronto |
More Information
No publications provided
| Responsible Party: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT01480908 History of Changes |
| Other Study ID Numbers: | VSDRBBBB-RV |
| Study First Received: | November 16, 2011 |
| Last Updated: | September 11, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by University of Aarhus:
|
Right bundle branch block Ventricular septal defect Echocardiography MRI Exercise testing |
Additional relevant MeSH terms:
|
Bundle-Branch Block Heart Block Heart Septal Defects Heart Septal Defects, Ventricular Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 16, 2013