The aim of this study is to investigate the relationship between atrial septal defects and airway responsiveness before and after percutaneous closure.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary ~: presence and extent of airway responsiveness at follow-up after
percutaneous ASD closure.
Secondary outcome
Secondary ~: difference in airway responsiveness between pre-procedural and
post-procedural measurements.
Background summary
Secundum atrial septal defects (ASDs) are the second most common congenital
heart defects. Appropriate and timely diagnosis and treatment prevents
complications of long-standing right ventricular volume overload such as
pulmonary hypertension and right-sided heart failure. Better understanding of
ASD-based dyspnea may help to distinguish it from other (non-)cardiac causes of
dyspnea, potentially preventing patients* and physicians* delay in diagnosing
ASD. Although seen as a clinical coincidence, adult ASD patients often report
dyspnea with wheezing, chest tightness and cough that may mimic bronchial
asthma. Airway hyperresponsiveness is a common feature of bronchial asthma and
characterizes by more sensitive and increased airway narrowing to nonspecific
stimuli that normally lead to little or no airway response. Both experimental
and clinical studies have reported its presence in mitral valve disease and
ischemic cardiomyopathy. ASD-based left-to-right shunting and the resulting
flow-mediated pulmonary vascular distention may be related to asthma-like
symptoms. If so, clinical awareness thereof can guide physicians to correctly
diagnose ASD in adults.
Study objective
The aim of this study is to investigate the relationship between atrial septal
defects and airway responsiveness before and after percutaneous closure.
Study design
Observational cohort study. Patients eligible for the study will undergo a
single lung function test consisting of spirometry and methacholine
provocation. Patients* baseline characteristics and documented symptoms and
lung function will be retrospectively studied to investigate the effect of
percutaneous closure on airway responsiveness.
Study burden and risks
No study-specific benefits and risks are anticipated for the subjects in the
study population.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62746.018.17 |