Pulmonary Arterial HypertensionNCT00609349
The Early Recognition of Pulmonary Arterial Hypertension
A study testing ETED, CPET, RHC in people with Pulmonary Arterial Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial summary
The early detection of pulmonary arterial hypertension may help to improve prognosis of the disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- ETED, CPET, RHC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2006to May 2009
- 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
- Systemic sclerosis
- SLE
- Late corrected left-right shunt
- HIV Infection
- Splenectomy over 10 years
- Haemoglobinopathy and Thrombocytosis
Show all 11Show fewer
- Ventriculo-atrial Shunt
- Liver cirrhosis/other portal Hypertension
- Anamnestic Aminorex or PhenFen abuse
- Close relatives of patients with IPAH
- Healthy controls
Who cannot join
- Known PAH
- Severe lung or bronchial disease (FEV1 <70% predicted)
- Systolic LV dysfunction (LVEF <50%) or diastolic dysfunction (pulmonary arterial "wedge" pressure (PAWP) ≥15 mmHg)
- Valvular dysfunction > Grad I (except of Tricuspidal- and Pulmonary insufficiency)
- Uncontrolled systemic arterial hypertension (rest >150 mmHg systolic or 90 mmHg diastolic; exercise >220 mmHg systolic)
- Uncontrolled ventricular arrythmia
Show all 11Show fewer
- Uncontrolled supraventricular arrythmia
- Myocardial infarction within last 12 months
- Pulmonary embolism within last 12 months
- Significant change in therapy or larger operation within last 12 weeks
- Inability of performing exercise on cycle ergometer
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University Graz, Division of Pulmonology
Graz, Styria, 8036
About this study
The early detection of pulmonary arterial hypertension may help to improve prognosis of the disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise. In the present study we investigate patients with risk factors for pulmonary arterial hypertension (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension and control the results by the gold standard right heart catheterisation at rest and during exercise. We expect that using this screening method, patients with pulmonary arterial hypertension would be recognized earlier.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a rare, life-threatening disease. It is characterised by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. A remodelling of small pulmonary vessels characterised by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level.
According to the actual classification of Venice (2003), PAH can be idiopathic, familiar or associated to other diseases and conditions (APAH). About 15 different clinical entities belong to the APAH group: connective tissue diseases such as systemic sclerosis, mixed connective tissue disease, or systemic lupus erythematodes being among the most frequent. The development of APAH in these diseases results in decreased survival. Successful therapies include prostanoids, endothelin receptor antagonists and phosphodiesterase-5 inhibitors, however, the effects in associated conditions appear smaller compared to idiopathic PAH. The early recognition of APAH may promote better treatment results and prognosis.
Hemodynamically, PAH has been defined as a mean pulmonary arterial pressure (MPAP) > 25mmHg at rest, or > 30mmHg during exercise.
It is assumed that in the early stages of PAH, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise (latent PAH).
Doppler echocardiography, by using the tricuspid regurgitation jet and the simplified Bernoulli-equation, is a well established clinical method for the estimation of systolic pulmonary arterial pressure at rest (rSPAP). A close correlation between rSPAP values from echo and right heart catheterisation (RHC) has been described. A promising non-invasive method to detect SPAP during exercise is Exercise Tricuspid Echo Doppler (ETED). Previous studies suggested, that SPAP during exercise can be assessed with ETED in patients with connective tissue diseases, and it was suggested that a considerable proportion of these patients suffered from latent PAH. However, the results of these studies were not controlled by the gold standard RHC. According to present guidelines, RHC is needed for the definite diagnosis of PAH, which allows the precise measurement of MPAP, pulmonary arterial wedge pressure, right atrial pressure and cardiac output, and the calculation of pulmonary vascular resistance.
Cardiopulmonary exercise testing (CPET) is a reliable method to objectively evaluate exercise capacity. Patients with latent PAH may suffer from dyspnea and early fatigue during exercise and may have a reduced exercise capacity. A low peak O2 uptake was associated with a poor prognosis in patients with PAH.
In the present study we investigate patients with risk factors for PAH by combining ETED and CPET and control the results by RHC at rest and during exercise.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- ETED, CPET, RHC
- Keywords
- risk factors for pulmonary arterial hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETED, CPET, RHCDevice
exercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2)
right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values
| Study group | Role | What they receive |
|---|---|---|
| connective tissue disease | Other | all patients suffer from a connective tissue disease representing a risk for the development of pulmonary hypertension Receives: Device: ETED, CPET, RHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary arterial pressure
Measured: measurements with right heart catheterisation within 1 month after exercise tricuspid doppler
Secondary outcomes (1)
exercise capacity (peakVO2, 6 minute walk distance)
Measured: controlled at 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startApr 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609349
- Sponsor's protocol ID
- 16-250 ex 04/05
- Status last verified
- Jan 2012
- First submitted
- 24 Jan 2008
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Hesse C, Troester N, Salmhofer W, Stauber R, Fuerst FC, Thonhofer R, Ofner-Kopeinig P, Gruenig E, Olschewski H. Assessment of pulmonary arterial pressure during exercise in collagen vascular disease: echocardiography vs right-sided heart catheterization. Chest. 2010 Aug;138(2):270-8. doi: 10.1378/chest.09-2099. Epub 2010 Apr 23.
PubMed 20418368Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Troster N, Hesse C, Salmhofer W, Graninger W, Gruenig E, Rubin LJ, Olschewski H. Borderline pulmonary arterial pressure is associated with decreased exercise capacity in scleroderma. Am J Respir Crit Care Med. 2009 Nov 1;180(9):881-6. doi: 10.1164/rccm.200904-0563OC. Epub 2009 Aug 13.
PubMed 19679693
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Recognition of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00609349
- Acronym / sponsor ID
- 16-250 ex 04/05
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- risk factors for pulmonary arterial hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Feb 2008 (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.
The early detection of pulmonary arterial hypertension may help to improve prognosis of the disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise. In the present study we investigate patients with risk factors for pulmonary arterial hypertension (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension and control the results by the gold standard right heart catheterisation at rest and during exercise. We expect that using this screening method, patients with pulmonary arterial hypertension would be recognized earlier.
Detailed description
Pulmonary arterial hypertension (PAH) is a rare, life-threatening disease. It is characterised by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. A remodelling of small pulmonary vessels characterised by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level.
According to the actual classification of Venice (2003), PAH can be idiopathic, familiar or associated to other diseases and conditions (APAH). About 15 different clinical entities belong to the APAH group: connective tissue diseases such as systemic sclerosis, mixed connective tissue disease, or systemic lupus erythematodes being among the most frequent. The development of APAH in these diseases results in decreased survival. Successful therapies include prostanoids, endothelin receptor antagonists and phosphodiesterase-5 inhibitors, however, the effects in associated conditions appear smaller compared to idiopathic PAH. The early recognition of APAH may promote better treatment results and prognosis.
Hemodynamically, PAH has been defined as a mean pulmonary arterial pressure (MPAP) > 25mmHg at rest, or > 30mmHg during exercise.
It is assumed that in the early stages of PAH, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise (latent PAH).
Doppler echocardiography, by using the tricuspid regurgitation jet and the simplified Bernoulli-equation, is a well established clinical method for the estimation of systolic pulmonary arterial pressure at rest (rSPAP). A close correlation between rSPAP values from echo and right heart catheterisation (RHC) has been described. A promising non-invasive method to detect SPAP during exercise is Exercise Tricuspid Echo Doppler (ETED). Previous studies suggested, that SPAP during exercise can be assessed with ETED in patients with connective tissue diseases, and it was suggested that a considerable proportion of these patients suffered from latent PAH. However, the results of these studies were not controlled by the gold standard RHC. According to present guidelines, RHC is needed for the definite diagnosis of PAH, which allows the precise measurement of MPAP, pulmonary arterial wedge pressure, right atrial pressure and cardiac output, and the calculation of pulmonary vascular resistance.
Cardiopulmonary exercise testing (CPET) is a reliable method to objectively evaluate exercise capacity. Patients with latent PAH may suffer from dyspnea and early fatigue during exercise and may have a reduced exercise capacity. A low peak O2 uptake was associated with a poor prognosis in patients with PAH.
In the present study we investigate patients with risk factors for PAH by combining ETED and CPET and control the results by RHC at rest and during exercise.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| connective tissue disease | Other | Device: ETED, CPET, RHCall patients suffer from a connective tissue disease representing a risk for the development of pulmonary hypertension |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Systemic sclerosis
- SLE
- Late corrected left-right shunt
- HIV Infection
- Splenectomy over 10 years
Key exclusion criteria (11 listed)
- Known PAH
- Severe lung or bronchial disease (FEV1 <70% predicted)
- Systolic LV dysfunction (LVEF <50%) or diastolic dysfunction (pulmonary arterial "wedge" pressure (PAWP) ≥15 mmHg)
- Valvular dysfunction > Grad I (except of Tricuspidal- and Pulmonary insufficiency)
- Uncontrolled systemic arterial hypertension (rest >150 mmHg systolic or 90 mmHg diastolic; exercise >220 mmHg systolic)
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 |
|---|---|---|
| ETED, CPET, RHCexercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2) right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values | Device | connective tissue disease |
Primary outcome
pulmonary arterial pressure
Time frame: measurements with right heart catheterisation within 1 month after exercise tricuspid doppler
1 secondary outcome
exercise capacity (peakVO2, 6 minute walk distance)
Time frame: controlled at 1 year after baseline
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 12 Jan 2012.
- Derived from this study: PubMed 20418368Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Hesse C, Troester N, Salmhofer W, Stauber R, Fuerst FC, Thonhofer R, Ofner-Kopeinig P, Gruenig E, Olschewski H. Assessment of pulmonary arterial pressure during exercise in collagen vascular disease: echocardiography vs right-sided heart catheterization. Chest. 2010 Aug;138(2):270-8. doi: 10.1378/chest.09-2099. Epub 2010 Apr 23.
- Derived from this study: PubMed 19679693Kovacs G, Maier R, Aberer E, Brodmann M, Scheidl S, Troster N, Hesse C, Salmhofer W, Graninger W, Gruenig E, Rubin LJ, Olschewski H. Borderline pulmonary arterial pressure is associated with decreased exercise capacity in scleroderma. Am J Respir Crit Care Med. 2009 Nov 1;180(9):881-6. doi: 10.1164/rccm.200904-0563OC. Epub 2009 Aug 13.
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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.
Horst Olschewski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETED, CPET, RHC in people with Pulmonary Arterial Hypertension, run by Medical University of Graz at 1 site in Austria.
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 11 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 12 Jan 2012. 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 Austria. 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 arterial pressure (time frame: measurements with right heart catheterisation within 1 month after exercise tricuspid doppler). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00609349, which also lists 2 linked publications.
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 12 Jan 2012.