Scleroderma, SystemicNCT01202045
Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients
An observational study of Scleroderma, Systemic and Hypertension, Pulmonary, run by Paul Farand at 1 site in Canada.
Trial summary
The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic, Hypertension, Pulmonary
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Oct 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Systemic slerosis patients with indirect signs of arterial pulmonary hypertension: * Effort dyspnea (NYHA >= 2/4) * DLCO < 60% * FVC% / DLCO% > 1.6 * SPAP > 40 mmhg and < 55 mmhg
Who may be able to join
- At least one of the prespecified indirect sign of pulmonary arterial hypertension
- Able to exercise on treadmill
Who cannot join
- left ventricular dysfunction at rest
- Absence of pulmonary regurgitant flow
- Pregnancy or breastfeeding
- Smoking with > 60 pack-year
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension
The purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.
Read the detailed description
Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.
- Conditions
- Scleroderma, Systemic, Hypertension, Pulmonary
- Keywords
- Echocardiography, Stress, right heart catheterization
- Medical subject headings
- Scleroderma, Systemic, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| systemic sclerosis patients | Every patient will have a rest echocardiography, a stress echocardiography, a right heart catheterization, a blood specimen, and a pulmonary function test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.
Every patient will have both procedures; stress echocardiography and right heart catheterization. A positive stress echocardiography is defined as >= 20 mmhg increase in the systolic pulmonary artery pressure (SPAP) (between rest and stress) or an absolute value >= 55 mmhg. A positive right heart catheterization at rest is defined as a PAPm >25mmhg, wedge < 18 and pulmonary vascular resistances >3 wood units. Stress catheterization will also be perform and is defined as a PAPm > 30mmhg and wedge <18 mm hg.
Measured: 5 years
Secondary outcomes (4)
Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP.
Measured: 5 years
Function of the left ventricle (left ventricular ejection fraction) at rest and at stress.
We hypothesize that patients who do not increase their left ventricular ejection fraction at stress have a worst clinical outcome in the follow up.
Measured: Follow up every year X 5
Diastolic function at rest and at stress
We hypothesize that patients with diastolic dysfunction manifesting at stress have a worst clinical outcome in the follow up.
Measured: follow up every year X 5
Function of the right ventricle
We hypothesise that in patients with or without pulmonary hypertension, right ventricular dysfunction is associated with a worse clinical outcome
Measured: Follow up every year X 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paul Farand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paul Farand, Université de Sherbrooke
- Investigators
- Paul Farand, md, msc, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202045
- Sponsor's protocol ID
- Projet # 10-111
- Status last verified
- Jul 2013
- First submitted
- 10 Sep 2010
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Echocardiography in the Detection of Pulmonary Arterial Hypertension in Systemic Sclerosis Patients With Indirect Signs of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01202045
- Acronym / sponsor ID
- Projet # 10-111
- Conditions
- Scleroderma, Systemic, Hypertension, Pulmonary
- Keywords
- Echocardiography, Stress, right heart catheterization
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Paul FarandUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (estimated)
- First posted
- 15 Sep 2010 (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 purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.
Detailed description
Pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| systemic sclerosis patients | – | –Every patient will have a rest echocardiography, a stress echocardiography, a right heart catheterization, a blood specimen, and a pulmonary function test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic slerosis patients with indirect signs of arterial pulmonary hypertension: * Effort dyspnea (NYHA >= 2/4) * DLCO < 60% * FVC% / DLCO% > 1.6 * SPAP > 40 mmhg and < 55 mmhg
Key inclusion criteria (2 listed)
- At least one of the prespecified indirect sign of pulmonary arterial hypertension
- Able to exercise on treadmill
Key exclusion criteria (4 listed)
- left ventricular dysfunction at rest
- Absence of pulmonary regurgitant flow
- Pregnancy or breastfeeding
- Smoking with > 60 pack-year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization.
Time frame: 5 years
Every patient will have both procedures; stress echocardiography and right heart catheterization. A positive stress echocardiography is defined as >= 20 mmhg increase in the systolic pulmonary artery pressure (SPAP) (between rest and stress) or an absolute value >= 55 mmhg. A positive right heart catheterization at rest is defined as a PAPm >25mmhg, wedge < 18 and pulmonary vascular resistances >3 wood units. Stress catheterization will also be perform and is defined as a PAPm > 30mmhg and wedge <18 mm hg.
4 secondary outcomes
Correlation of a 20 mmhg increase in the PAP during stress echocardiography and elevated NT-proBNP.
Time frame: 5 years
Function of the left ventricle (left ventricular ejection fraction) at rest and at stress.
Time frame: Follow up every year X 5
Diastolic function at rest and at stress
Time frame: follow up every year X 5
Function of the right ventricle
Time frame: Follow up every year X 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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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.
Paul Farand, md, msc principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scleroderma, Systemic and Hypertension, Pulmonary, run by Paul Farand at 1 site in Canada.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jul 2013. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Correlation of a 20 mmhg increase in the pulmonary artery pressures (PAP) during stress echocardiography and PAP using right heart catheterization. (time frame: 5 years). 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 8 Jul 2013.