The pulmonary effect of bronchodilation on adult VSD patients with persistent or surgically corrected VSD

INTERVENTION: Trade Name: Ventoline Inhalationsspray, suspension 0,1 mg/dosis Product Name: Ventoline Pharmaceutical Form: Inhalation solution INN or Proposed INN: SALBUTAMOL SULFATE CAS Number: 51022‐70‐9 Other descriptive name: SALBUTAMOL SULFATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use CONDITION: ; MedDRA version: 19.1 Level: PT Classification code 10047298 Term: Ventricular septal defect System Organ Class: 10010331 ‐ Congenital, familial and genetic disorders Therapeutic area: Diseases [C] ‐ Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] PRIMARY OUTCOME: Main Objective: The overall purpose of this study is to test whether ß2‐agonists will affect the cardiopulmonary exercise capacity of VSD‐operated patients compared with un‐operated VSD‐patients and healthy age‐ and gender‐matched controls Primary end point(s): Peak minute ventilation (ml min‐1); Peak exercise oxygen uptake (ml O2 kg‐1 min‐1); Peak workload Secondary Objective: Furthermore we will investigate if the ß2‐agonists will affect the pulmonary function and heart‐rate‐variability of VSD‐operated patients compared with un‐operated VSD‐patients and healthy age‐ and gender‐matched controls. Timepoint(s) of evaluation of this end point: Last patient is scheduled to be included no later than september 30th 2017. After this data analysis will commence. SECONDARY OUTCOME: Secondary end point(s): Lung clearance index: LCI 2,5 ‐ Scond ‐ Sacin; ; Plethymography: TLC, RV, FRCpleth, sRAW,; ; Spirometry: FEV1 FVC, FEV1/FVC; ; Diffusion capacity: DLCO, VA (alveolar volume), ; ; Impulse Oscillometry: Diff 5‐20; ; Heart‐rate variability: HRV, mean RR interval, RMSSD, arrhythmias discovered; ; Timepoint(s) of evaluation of this end point: Last patient is scheduled to be included no later than september 30th 2017. After this data analysis will commence. 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 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