EUCTR2015-005507-89-DK
Active, not recruiting
Phase 1
The pulmonary effect of bronchodilation on adult VSD patients with persistent or surgically corrected VSD - VENTI Trial
Department of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital0 sites110 target enrollmentJune 9, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 19.1Level: PTClassification code 10047298Term: Ventricular septal defectSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
- Sponsor
- Department of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
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 1977 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\-40 years, with no known medical records of heart and lung disease.
- •Restrain from strenuous leg exercise 24 hours before inclusion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Lack of medical record.
- •\- 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 ß2\-responsive conditions.
- •Coronary heart disease.
- •Severe pulmonary disease.
Outcomes
Primary Outcomes
Not specified
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