Pulmonary Vascular DiseaseNCT02648984
Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With Closed Ventricular Septal Defect
A study testing The intervention is performing an exercise test in people with Pulmonary Vascular Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Vascular Disease
- What is being tested?
- The intervention is performing an exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- Impairment of organic function (renal, hepatic)
- Arterial hypotension (systolic blood pressure < 85 mmHg)
- Anaemia (Hb < 10 g/dl)
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- 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
Who cannot join
- Other congenital heart disease
- PAH of any aetiology other than VSD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect
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.
Read the 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.
- Conditions
- Pulmonary Vascular Disease
- Being tested
- The intervention is performing an exercise test
- Keywords
- Pulmonary vascular disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is performing an exercise testOther
Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Other | Patients with ventricular septal defect Receives: Other: The intervention is performing an exercise test |
| Control group | Other | Healthy control subjects Receives: Other: The intervention is performing an exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary artery pressure - flow plot
Measured: Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
Secondary outcomes (1)
Maximal Oxygen Uptake
Measured: Through study completion, an average of 1,5 years for the first testing, an additional 1 year for the retesting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startSep 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Werner Budts, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Werner Budts, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648984
- Sponsor's protocol ID
- S56272
- Status last verified
- May 2017
- First submitted
- 30 Dec 2015
- Last updated
- 5 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ad Hoc Analysis for the Evaluation of Dynamic Pulmonary Vascular Resistance in Patients With a Closed Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT02648984
- Acronym / sponsor ID
- S56272
- Conditions
- Pulmonary Vascular Disease
- Keywords
- Pulmonary vascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Other | Other: The intervention is performing an exercise testPatients with ventricular septal defect |
| Control group | Other | Other: The intervention is performing an exercise testHealthy control subjects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Impairment of organic function (renal, hepatic)
- Arterial hypotension (systolic blood pressure < 85 mmHg)
Key exclusion criteria (2 listed)
- Other congenital heart disease
- PAH of any aetiology other than VSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention is performing an exercise testPatients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test | Other | Control group, Patient group |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Budts, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention is performing an exercise test in people with Pulmonary Vascular Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.