Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect
Primary Purpose
Pulmonary Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
The intervention is performing an exercise test
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Vascular Disease focused on measuring Pulmonary vascular disease
Eligibility Criteria
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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient group
Control group
Arm Description
Patients with ventricular septal defect
Healthy control subjects
Outcomes
Primary Outcome Measures
Pulmonary artery pressure - flow plot
Secondary Outcome Measures
Maximal Oxygen Uptake
Full Information
NCT ID
NCT02648984
First Posted
December 30, 2015
Last Updated
May 2, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT02648984
Brief Title
Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect
Official Title
Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Vascular Disease
Keywords
Pulmonary vascular disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Other
Arm Description
Patients with ventricular septal defect
Arm Title
Control group
Arm Type
Other
Arm Description
Healthy control subjects
Intervention Type
Other
Intervention Name(s)
The intervention is performing an exercise test
Intervention Description
Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test
Primary Outcome Measure Information:
Title
Pulmonary artery pressure - flow plot
Time Frame
Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
Secondary Outcome Measure Information:
Title
Maximal Oxygen Uptake
Time Frame
Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Budts, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect
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