Clinical trial NCT01480908: Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect
Official title: Postoperative Right Bundle Branch Block - Long-term Effect on the Right Ventricle in Children Operated for Ventricular Septal Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bundle-Branch Block
Heart Septal Defects, Ventricular
Keywords: Right bundle branch block
Ventricular septal defect
Echocardiography
MRI
Exercise testing
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital Skejby
First posted: 2011-11-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic function at rest measured by echocardiography
timeFrame: All patients are tested only once about 20 years post to surgery
Secondary outcomes:
measure: Maximal oxygen consumption during exercise
timeFrame: All patients are tested only once about 20 years post to surgery
measure: Force-frequency-relation during exercise
timeFrame: All patients are tested only once about 20 years post to surgery
measure: Diastolic function at rest measured by MRI
timeFrame: All patients are tested only once about 20 years post to surgery
measure: Diastolic function at rest measured by echocardiography
timeFrame: All patients are tested only once about 20 years post to surgery
measure: Systolic function at rest measured by MRI
timeFrame: All patients are tested only once about 20 years post to surgery
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby
state: Aarhus N
Study officials:
affiliation: Dept. of Cardiothoracic surgery, Aarhus Universitetshospital Skejby
name: Vibeke Hjortdal, MD, DMSc, Prof.
role: STUDY_CHAIR
affiliation: Dept. of Cardiology, Aarhus University Hospital Skejby
name: Michael R. Schmidt, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept. MRI, Aarhus University Hospital Skejby
name: Steffen Ringgaard, Physics, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Cardiology, The Hospital for Sick Children, Toronto
name: Andrew Redington, MD, DMSc, Prof.
role: STUDY_DIRECTOR
References: