Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02648984
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2015-12-30
Brief Title:
Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH in patients with congenital heart disease usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt This overload leads to elevated pulmonary artery pressure PAP and later to increased pulmonary vascular resistance PVR leading to right ventricular dysfunction considerable morbidity and even mortality
Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated the disease already evolved to an advanced stage and treatment is often initiated too late Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography The investigators now aim to assess this exercise technique in a group of patients with ventricular septal defect
Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated the disease already evolved to an advanced stage and treatment is often initiated too late Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography The investigators now aim to assess this exercise technique in a group of patients with ventricular septal defect
Detailed Description:
Pulmonary arterial hypertension PAH in patients with congenital heart disease usually develops secondary to chronic volume overload of the pulmonary circulation following left to right shunt This overload leads to elevated pulmonary artery pressure PAP and later to increased pulmonary vascular resistance PVR PAH may lead to right ventricular and right atrial dysfunction which may implicate considerable morbidity and even mortality
Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated the disease already evolved to an advanced stage and treatment is often initiated too late Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography Exercise-induced pulmonary hypertension has been recognised as a clinical entity but is not included in the current guidelines on pulmonary hypertension Further research in this area might imply the need for revision of the current PAH detection and treatment strategy
By performing stress echocardiography and cardiopulmonary exercise testing the investigators want to reach the following objectives
To answer the question whether the abnormal increase in PAP during exercise seen in patients with late atrial septal defect ASD type secundum closure is also present in congenital heart disease CHD patients who were treated for other shunt lesions
To apply this early detection technique in a broader population of CHD patients and to better define the predictive value of an elevated PVR during exercise
Since PAH nowadays is mostly detected when symptoms occur and PAP are elevated the disease already evolved to an advanced stage and treatment is often initiated too late Our research group standardized the technique for the detection of early pulmonary vascular disease by bicycle stress echocardiography Exercise-induced pulmonary hypertension has been recognised as a clinical entity but is not included in the current guidelines on pulmonary hypertension Further research in this area might imply the need for revision of the current PAH detection and treatment strategy
By performing stress echocardiography and cardiopulmonary exercise testing the investigators want to reach the following objectives
To answer the question whether the abnormal increase in PAP during exercise seen in patients with late atrial septal defect ASD type secundum closure is also present in congenital heart disease CHD patients who were treated for other shunt lesions
To apply this early detection technique in a broader population of CHD patients and to better define the predictive value of an elevated PVR during exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None