The effect of airway dilation on heart and lung function in adult patients born with ventricular septal heart defects

Phase 1

• Conditions: MedDRA version: 19.1Level: PTClassification code 10047298Term: Ventricular septal defectSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-005507-89-DK
• Lead Sponsor: Department of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-09
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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

Exclusion Criteria

Lack of medical record.

Pregnancy.
- 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.

Diabetes.

Use of the following medication: Xantin-derivates, steroids, diuretics, ipratropium.

Allergy to the active ingredients of Ventoline: Salbutamolsulphate, benzalkoniumchloride

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;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.;Primary end point(s): Peak minute ventilation (ml min-1)<br>Peak exercise oxygen uptake (ml O2 kg-1 min-1)<br>Peak workload;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 Measures

Name	Time	Method
Secondary end point(s): Lung clearance index: LCI 2,5 - Scond - Sacin<br><br>Plethymography: TLC, RV, FRCpleth, sRAW,<br><br>Spirometry: FEV1 FVC, FEV1/FVC<br><br>Diffusion capacity: DLCO, VA (alveolar volume), <br><br>Impulse Oscillometry: Diff 5-20<br><br>Heart-rate variability: HRV, mean RR interval, RMSSD, arrhythmias discovered<br><br>;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.