Pulmonary Arterial HypertensionNCT02885155
Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Central Hospital, Nancy, France.
Trial summary
The purpose of this study is to determine the prognostic value of echocardiographic parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial hypertension (PAH). A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Echocardiography and Hemodynamic examinations (right cardiac catheterization)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jan 2012
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary arterial hypertension followed at CHU Nancy.
Who may be able to join
- Mean pulmonary artery pressure > 25 mmHg in hemodynamics
- according to Venice classification: Idiopathic PAH or associated to other known risk factors (anorectics, portal hypertension, connective tissue diseases, in particular scleroderma but also lupus, congenital heart disease with Eisenmenger syndrome, HIV infection)
Who cannot join
- Atrial fibrillation
- Poor echogenicity
- PAH associated to another factor, thromboembolic disease, respiratory insufficiency, left heart disease or mitral or aortic valvulopathy
About this study
The purpose of this study is to determine the prognostic value of echocardiographic parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial hypertension (PAH).
A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. In pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical parameters between 2 examinations has a prognostic interest. In this study the prognostic value of variation of some echocardiographic parameters between initial examination and echocardiography after 3 or 6 months will be evaluated.
Another secondary purpose is to create a common database for Pneumology, Cardiology and Epidemiology departments with prospective registration of new cases of PAH and follow of patients under treatment.
Read the detailed description
Pulmonary arterial hypertension (PAH) is a rare pathology with a poor prognosis and a median survival lower than 3 years in the absence of a specific treatment.
The prognostic evaluation is based on clinical and hemodynamic data needing the right cardiac catheterization. It has been shown that prognosis depends essentially on the severity of right ventricular dysfunction. Recently, various echocardiographic parameters derived from new techniques such as tissue Doppler have been validated for the evaluation of right ventricular function. Some have been used as prognostic factor in cardiac insufficiency, but not in PAH.
This is an observational retrospective and then prospective study. Usual PAH assessment includes a complete clinical and paraclinical evaluation. History and physical examination assess dyspnea, search signs of disease severity and quantify functional impact of 6 min-walking test. An echocardiography and a right cardiac catheterization are realized in all patients. Clinical consultations of patients and control echocardiographic and hemodynamic examinations are programmed at regular intervals.
The demonstration of prognostic value of some echocardiographic parameters could diminish right cardiac catheterizations.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Echocardiography, Hemodynamic examinations (right cardiac catheterization)
- 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.
EchocardiographyOther
planned at regular intervals
Hemodynamic examinations (right cardiac catheterization)Other
planned at regular intervals
| Study group | Role | What they receive |
|---|---|---|
| Patients with pulmonary arterial hypertension | Not described Receives: Other: Echocardiography; Other: Hemodynamic examinations (right cardiac catheterization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Chabot, Pr, Principal investigator, Service de Maladies Respiratoires et Réanimation Respiratoire - CHU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885155
- Sponsor's protocol ID
- 2006CPRC/CHABOT
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Echocardiography to Prognostic Evaluation of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02885155
- Acronym / sponsor ID
- 2006CPRC/CHABOT
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to determine the prognostic value of echocardiographic parameters in comparison with clinical and hemodynamic parameters in pulmonary arterial hypertension (PAH).
A secondary purpose of this study is to analyze the disease evolution after 3 to 6 months. In pulmonary fibrosis it has been demonstrated that the variation of clinical and paraclinical parameters between 2 examinations has a prognostic interest. In this study the prognostic value of variation of some echocardiographic parameters between initial examination and echocardiography after 3 or 6 months will be evaluated.
Another secondary purpose is to create a common database for Pneumology, Cardiology and Epidemiology departments with prospective registration of new cases of PAH and follow of patients under treatment.
Detailed description
Pulmonary arterial hypertension (PAH) is a rare pathology with a poor prognosis and a median survival lower than 3 years in the absence of a specific treatment.
The prognostic evaluation is based on clinical and hemodynamic data needing the right cardiac catheterization. It has been shown that prognosis depends essentially on the severity of right ventricular dysfunction. Recently, various echocardiographic parameters derived from new techniques such as tissue Doppler have been validated for the evaluation of right ventricular function. Some have been used as prognostic factor in cardiac insufficiency, but not in PAH.
This is an observational retrospective and then prospective study. Usual PAH assessment includes a complete clinical and paraclinical evaluation. History and physical examination assess dyspnea, search signs of disease severity and quantify functional impact of 6 min-walking test. An echocardiography and a right cardiac catheterization are realized in all patients. Clinical consultations of patients and control echocardiographic and hemodynamic examinations are programmed at regular intervals.
The demonstration of prognostic value of some echocardiographic parameters could diminish right cardiac catheterizations.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with pulmonary arterial hypertension | – | Other: Echocardiography, Other: Hemodynamic examinations (right cardiac catheterization) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary arterial hypertension followed at CHU Nancy.
Key inclusion criteria (2 listed)
- Mean pulmonary artery pressure > 25 mmHg in hemodynamics
- according to Venice classification: Idiopathic PAH or associated to other known risk factors (anorectics, portal hypertension, connective tissue diseases, in particular scleroderma but also lupus, congenital heart disease with Eisenmenger syndrome, HIV infection)
Key exclusion criteria (3 listed)
- Atrial fibrillation
- Poor echogenicity
- PAH associated to another factor, thromboembolic disease, respiratory insufficiency, left heart disease or mitral or aortic valvulopathy
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 |
|---|---|---|
| Echocardiographyplanned at regular intervals | Other | Patients with pulmonary arterial hypertension |
| Hemodynamic examinations (right cardiac catheterization)planned at regular intervals | Other | Patients with pulmonary arterial hypertension |
Primary outcome
Mortality at 5 years
Time frame: 5 years
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 31 Aug 2016.
- Individual participant dataSharing planned: No
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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.
François Chabot, Pr principal investigator
Service de Maladies Respiratoires et Réanimation Respiratoire - CHU Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Central Hospital, Nancy, France.
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 3 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 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality at 5 years (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 31 Aug 2016.