Pulmonary Vascular Disease Clinical Trial
Official title:
Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect
Verified date | May 2017 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Male or female subjects with ventricular septal defect (VSD) repair at least 6 months before study enrolment - No discrimination in type of VSD repair will be made (percutaneous or surgical) - Subjects must be able to perform exercise testing Exclusion Criteria: - Other congenital heart disease - PAH of any aetiology other than VSD - Inclusion in other treatment protocols - Impairment of organic function (renal, hepatic) - Arterial hypotension (systolic blood pressure < 85 mmHg) - Anaemia (Hb < 10 g/dl) - Thrombocytopenia (< 50000/µl) - Significant valvular disease, other than tricuspid or pulmonary regurgitation - Chronic lung disease or total lung capacity < 80% of predicted value - History of pulmonary embolism - Cyanotic patients, patients in an unstable condition and patients who have to undergo re-intervention during the study |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pulmonary artery pressure - flow plot | Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting | ||
Secondary | Maximal Oxygen Uptake | Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting |
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