The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.
Ventricular Septal Defect
About this trial
This is an interventional treatment trial for Ventricular Septal Defect focused on measuring Congenital Heart Disease, Ventricular Septal Defect, Beta-2-agonists, Surgery, Follow-up
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age and legally competent to vouch for their own study participation.
- Informed and written consent for participation in this trial.
- Trial group 1: Surgically corrected for isolated VSD between 1990 and 1998 at Aarhus University Hospital.
- Trial group 2: Diagnosed with isolated VSD born between 1985 and 1998 without surgical or percutaneous closure. Verified by Echocardiography within the last 4 years. If it is more than 4 it will be verified by our doctors as a systolic murmur or echocardiography.
- Trial group 3: 18-30 years, with no known medical records of heart and lung disease.
- Restrain from strenuous leg exercise 24 hours before inclusion.
Exclusion Criteria:
- Lack of medical record.
Pregnancy.
o Participants will be asked if they are using contraceptives and be told to continue this during the trial and for at least 30 hours (5 times T2) after their last visit. If they are not using spiral or valid contraceptives (contraceptive pills, implants, transdermal patches, vaginal ring or injections) one of our medical experts will judge if the participant is able to undergo the trial. They will likewise be informed to withstand from sexual intercourse during the trial until 30 hours after the second visit.
- Currently breastfeeding.
- Syndromes, such as Down's.
- Mentally or physically incompetent to perform the ergometer bicycle test.
- Thyrotoxicosis.
- Pre-trial medical record of arrhythmias except right bundle branch block.
- Asthma or other known β2-responsive conditions.
- Coronary heart disease.
- Severe pulmonary disease.
- Diabetes.
- Use of the following medication: Xantin-derivates, steroids, diuretics, ipratropium.
- Allergy to the active ingredients of Ventoline: Salbutamolsulphate, benzalkoniumchloride
The product summary was used to establish exclusion criteria in regards to medication and diseases that aren't eligible with the medical treatment. Other medication than described in the in- and exclusion criteria will be noted in the participants CRF. If the participant takes any special medication one of our trial doctors will determine if the participant should be excluded.
Participants will be informed of the exclusion criteria in the information letter and at the initial information interview before inclusion in the trial. Oral verification is considered sufficient to verify the exclusion criteria.
Sites / Locations
- Dept. of Cardiothoracic and Vascular Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Operated VSD's
Un-operated VSD's
Healthy controls
Through the use of Electronic Patient Journal (EPJ), the investigators have identified a total of 182 children who underwent surgical closure of a congenital VSD at Aarhus University Hospital, Denmark between 1990 and 1995. After thorough review of all charts, 117 patients were excluded from participation. Exclusion criteria were coexistence of other congenital heart defects (n=89), associated syndromes, e.g. Down's (n=14), operation through a ventricular approach (n=7), missing chart (n=6) and documented arrhythmia requiring pacemaker (n=1). The remaining 68 patients represent a homogeneous group comparing surgeons, anaesthetists, surgical procedure and post-surgical period. A fraction of this group will be randomly selected for this trial, and receives salbutamol or norflouran, blinded.
Using EPJ, this project identified a total of 481 children born between 1985 and 1998 who had a small VSD, confirmed through diagnosis codes, that was not closed, neither spontaneously nor surgically. Exclusion criteria were lack of medical record, suffering from coronary disease, other congenital cardiac abnormalities than VSD, spontaneous closure of the ventricular septal defect at inclusion date, magnetic implants, pregnancy, lack of Danish language skills, suffering from lung disease requiring continuous medical treatment. The remaining patients represent a homogenous group of patients with isolated persistent ventricular septal defects. A fraction of this group will be randomly selected for this trial, and receives salbutamol or norflouran, blinded.
Will function as a control group. Controls will be recruited through www.forsoegsperson.dk and www.sundhed.dk. Current group receives salbutamol or norflouran, blinded.