Right Bundle Branch Block After Surgical Closure of Ventricular Septal Defect

This study is currently recruiting participants.
Verified August 2013 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01480908
First received: November 16, 2011
Last updated: August 5, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: June 2014 (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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480908

Contacts
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

Locations
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         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Investigators
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: August 5, 2013
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 April 16, 2014