The Cardiopulmonary Effect of Inhaled Beta-2-agonists on Adult Patients Born With Ventricular Septum Defects.

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective for this study is to test whether β2-agonists will affect the cardiopulmonary capacity of VSD-operated patients compared with un-operated VSD-patients and healthy age- and gender-matched controls.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Aarhus
• Treatments: Albuterol

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.