The Relationship between Atrial SEptal Defects (ASD) And BRonChial Hyperresponsiveness (SEARCH); Towards understanding the mechanism of dyspnea in adult ASD patients.

Completed

• Conditions: airway hyperresponsiveness; an airway reaction to a non-specific trigger (methacholine) that would normally not excite significant airway narrowing.; 10010394; 10007510; 10006436

• Registration Number: NL-OMON44433
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

*Adult age (> 18 years)
*Secundum ASD successfully closed using a septal occluder
*Available spirometry and methacholine provocation test results from before percutaneous ASD closure.

Exclusion Criteria

Absolute contraindications
o Severe airflow limitation (FEV1 <50% predicted or <1L)
o Myocardial infarction or stroke in last three months
o Uncontrolled hypertension (systolic BP >200mmHg or diastolic BP >100mmHg)
Relative contraindications:
o Moderate airflow limitation (FEV1 <60% predicted or <1.5L)
o Inability to perform acceptable-quality spirometry
o Pregnancy
o Nursing mothers

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary ~: presence and extent of airway responsiveness at follow-up after<br /><br>percutaneous ASD closure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary ~: difference in airway responsiveness between pre-procedural and<br /><br>post-procedural measurements.</p><br>