EUCTR2015-005507-89-DK进行中（未招募）1 期
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 个研究点目标入组 110 人开始时间: 2016年6月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •=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
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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.
- •Use of the following medication: Xantin-derivates, steroids, diuretics, ipratropium.
- •Allergy to the active ingredients of Ventoline: Salbutamolsulphate, benzalkoniumchloride
研究者
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