Primary Objective: Identification of patient characteristics, echocardiographic measurements and biomarkers that can contribute to a better selection of patients that benefit from percutaneous ASD closure at adult age. Secondary Objectives:-…
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Cardiac and vascular disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Non-responders after percutaneous ASD closure will be defined as:
- Sustained echocardiographic RV dysfunction after one year (eyeballing, right
ventricular fractional area change <35%, TAPSE <17 mm);
- Sustained high RV pressures after one year (measured by tricuspid
regurgitation maximal velocity >2.8 m/s).
Secondary outcome
The serial evolution of several variables will be investigated, in order to
gain more insight in the pathophysiological consequences of volume-load
reduction on the right heart:
- Biomarkers: NT-proBNP and other biomarkers that may arise to be potentially
important during the execution of this study.
- Conventional echocardiography: RV dimensions, RV systolic function, LV
dimensions, LV systolic and diastolic function;
- Speckle tracking echocardiography: global and segmental longitudinal strain
of the RV and LV.
Background summary
The atrial septal defect (ASD) is a common congenital cardiac anomaly,
accounting for approximately 10% of congenital cardiac anomalies.(1) Increased
pulmonary flow caused by left-to-right shunting can lead to pulmonary arterial
hypertension in a subset of patients.(2) Left untreated, the consequent
increase in pulmonary vascular resistance may cause progressive deterioration
of right ventricular (RV) function and eventually death.(3,4) Therefore, ASD
closure is performed in patients with significant shunts causing RV volume
overload, unless specific contra-indications are present.(5)
As ASDs are usually detected and closed in childhood, less is known about the
effects of ASD closure in adult patients. Previous studies have already shown
that the adult heart continues to hold an ability to reverse remodel after
removing the volume-overload, as right atrial and ventricular volumes were
significantly smaller after ASD closure.(6) Presumably, these reverse
remodelling processes are accompanied by subtle molecular changes in the heart.
It remains unknown which biomarkers can best reflect these processes and to
what extent biomarkers can contribute to the selection of patients that may
benefit from ASD closure at adult age.
This observational, longitudinal cohort study aims to perform serial biomarker
measurements in adult patients before, short-term after and long-term after
percutaneous ASD closure. This will gain more insight in the pathophysiological
consequences of volume-load reduction on the right heart. Moreover, this might
contribute to a better selection of patients that actually benefit from ASD
closure at adult age.
Study objective
Primary Objective:
Identification of patient characteristics, echocardiographic measurements and
biomarkers that can contribute to a better selection of patients that benefit
from percutaneous ASD closure at adult age.
Secondary Objectives:
- Identification of biomarkers that reflect reverse or adverse cardiac
remodelling processes after percutaneous ASD closure in adult patients.
- Detect echocardiographic changes after percutaneous ASD closure in adult
patients.
Study design
This is a prospective, observational cohort study with invasive measurements
(drawing of blood samples). All adult patients who are scheduled to undergo
percutaneous ASD closure in our center will be approached. Study inclusion
implies that blood samples will be drawn during or right before the procedure,
1 day after the procedure, 3 months and 1 year after the procedure. During the
3 months and 1-year follow-up, patients already visit the outpatient cardiology
clinic for a regular follow-up visit. Drawing of blood samples will be combined
with these outpatient follow-up visits. ECG and echocardiography measurements,
performed as part of routine clinical care during these outpatient visits, will
be additionally collected in our database. For each study subject the total
study duration will be one year.
Study burden and risks
For this study, blood samples (7 tubes, 44 mL blood) will be obtained at four
different time points. All other investigations in this study are part of
routine clinical care. Therefore, risks for the patients can be considered
negligible.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Scheduled to undergo percutaneous ASD closure in the Erasmus MC;
- Capable of understanding and signing informed consent.
Exclusion criteria
- Patients living abroad or who are not Dutch speaking;
- Age <18 years;
- Renal impairment (serum creatinine >200 umol/L);
- Failure of percutaneous ASD closure due to procedural problems.
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 | NL53428.078.15 |