Pulmonary HypertensionEFORTNCT01185730
Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics
A study testing Right Heart Catheterization in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this clinical research is to analyze the survival of a cohort of patients newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic factors using a dynamic model for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Right Heart Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged over 18 years
- With pulmonary arterial hypertension (PAH) idiopathic, hereditary or associated with the use of anorectics, newly diagnosed (less than 6 months) whose diagnosis was made by cardiac catheterization finding a mean pulmonary arterial pressure (mPAP)> 25 mm Hg at rest or> 30 mm Hg during exercise, with a pressure pulmonary artery occlusion (PAOP) ≤ 15 mm Hg,
- Has given his free and informed consent.
Who cannot join
- Minor (age <18 years)
- PAH patients whose diagnosis was there more than 6 months (prevalent cases),
- Patient with PAH associated with concomitant disease (autoimmune disease, portal hypertension, HIV infection, congenital heart disease, schistosomiasis, chronic hemolytic anemia)
- Patient with veno-occlusive disease and / or pulmonary capillary hemangiomatosis suspected or documented
- Patients with pulmonary hypertension associated with left heart (pulmonary hypertension post-capillary)
- Patients with pulmonary hypertension associated with respiratory disease (chronic obstructive pulmonary disease, pulmonary fibrosis, sleep apnea syndrome Sleep)
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- Patients with pulmonary hypertension post-embolic chronic
- Patient with pulmonary hypertension associated with sarcoidosis, histiocytosis X, a Lymphangioleiomyomatosis to mediastinal fibrosis,
- Adults protected
- Pregnant or lactating
- Persons deprived of liberty
- Persons in emergency situations,
- Persons who refused or unable to give informed consent.
- No affiliation to a social security scheme (beneficiary or beneficiary)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension
The objective of this clinical research is to analyze the survival of a cohort of patients newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic factors using a dynamic model for predicting survival, including prognostic factors evaluated repeatedly at pre-specified periods during follow-up. In a second step, the investigators define using this model combinations of parameters to better define the therapeutic goals in PAH (functional class, exercise testing, hemodynamic, echocardiographic variables, biological parameters).
Read the detailed description
Pulmonary arterial hypertension (PAH) is a rare disease characterized by an intense proliferation of pulmonary arterial wall causing increased progressive pulmonary vascular resistance, leading to right heart failure and death. Established prognostic factors at diagnosis were identified 20 years ago at a time when there is no specific treatment for describing the natural history of disease.
Over the last 10 years, new therapeutic classes (similar to prostacyclin, antagonists of endothelin receptors, inhibitors of phosphodiesterase 5) have been developed and improved symptoms, exercise capacity, and hemodynamics in patients with PAH. With the availability of these new molecules, the clinician is now faced with difficult treatment decisions regarding the choice of initial treatment and the need for road treatments combined during evolution. Therapeutic purpose and effect of these different therapeutic strategies on the long-term survival remain poorly understood.
If it has been clearly demonstrated that clinical parameters (NYHA functional class), functional (test 6-minute walk) and hemodynamic (cardiac output and pulmonary vascular resistance) measured before initiation of treatment have a major role in determining the prognosis, with the contribution of new molecules is important to evaluate the prognostic value of changes in these factors during follow-up under specific treatment. At the baseline assessment, including repeat cardiac catheterization rights, it is also important to evaluate other prognostic criteria substitution, including methods of noninvasive evaluation (echocardiography, biomarkers).
- Conditions
- Pulmonary Hypertension
- Being tested
- Right Heart Catheterization
- Keywords
- Pulmonary hypertension, Prognostic factors, Idiopathic pulmonary hypertension, Family pulmonary hypertension, use anorectics
- Medical subject headings
- Hypertension, Pulmonary, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right Heart CatheterizationProcedure or surgery
all patients of the all centers will have Right Heart Catheterization at the diagnosis
| Study group | Role | What they receive |
|---|---|---|
| pulmonary hypertension | Experimental | cohort of patients with pulmonary hypertension Receives: Procedure: Right Heart Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
death frequency
Measured: 12 months
Secondary outcomes (1)
death frequency
A dynamic model for predicting survival will be used, including prognostic factors evaluated repeatedly at pre-specified periods during follow-up:
- Right Heart Catheterization: mean pulmonary arterial pressure at rest or during exercise, and pressure pulmonary artery occlusion
- Echocardiographic variables
- Biomarkers (brain natriuretic peptide(BNP), N Terminal Pro BNP, Big-endothelin, Isoprostanes)
- Functional Class of the New York Heart Association(NYHA)
- Walk Test 6 minutes
Measured: Evolution between baseline assessment and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier SITBON, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185730
- Sponsor's protocol ID
- AOM 09065
- Acronym
- EFORT
- Status last verified
- Mar 2016
- First submitted
- 5 Aug 2010
- Last updated
- 11 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01185730
- Acronym / sponsor ID
- EFORT / AOM 09065
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Prognostic factors, Idiopathic pulmonary hypertension, Family pulmonary hypertension, use anorectics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 20 Aug 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 objective of this clinical research is to analyze the survival of a cohort of patients newly diagnosed (incident cases) with idiopathic PAH, familial or associated with the use of anorectics (isolated pulmonary vascular disease without comorbidity) and identify prognostic factors using a dynamic model for predicting survival, including prognostic factors evaluated repeatedly at pre-specified periods during follow-up. In a second step, the investigators define using this model combinations of parameters to better define the therapeutic goals in PAH (functional class, exercise testing, hemodynamic, echocardiographic variables, biological parameters).
Detailed description
Pulmonary arterial hypertension (PAH) is a rare disease characterized by an intense proliferation of pulmonary arterial wall causing increased progressive pulmonary vascular resistance, leading to right heart failure and death. Established prognostic factors at diagnosis were identified 20 years ago at a time when there is no specific treatment for describing the natural history of disease.
Over the last 10 years, new therapeutic classes (similar to prostacyclin, antagonists of endothelin receptors, inhibitors of phosphodiesterase 5) have been developed and improved symptoms, exercise capacity, and hemodynamics in patients with PAH. With the availability of these new molecules, the clinician is now faced with difficult treatment decisions regarding the choice of initial treatment and the need for road treatments combined during evolution. Therapeutic purpose and effect of these different therapeutic strategies on the long-term survival remain poorly understood.
If it has been clearly demonstrated that clinical parameters (NYHA functional class), functional (test 6-minute walk) and hemodynamic (cardiac output and pulmonary vascular resistance) measured before initiation of treatment have a major role in determining the prognosis, with the contribution of new molecules is important to evaluate the prognostic value of changes in these factors during follow-up under specific treatment. At the baseline assessment, including repeat cardiac catheterization rights, it is also important to evaluate other prognostic criteria substitution, including methods of noninvasive evaluation (echocardiography, biomarkers).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulmonary hypertension | Experimental | Procedure: Right Heart Catheterizationcohort of patients with pulmonary hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or woman aged over 18 years
- With pulmonary arterial hypertension (PAH) idiopathic, hereditary or associated with the use of anorectics, newly diagnosed (less than 6 months) whose diagnosis was made by cardiac catheterization finding a mean pulmonary arterial pressure (mPAP)> 25 mm Hg at rest or> 30 mm Hg during exercise, with a pressure pulmonary artery occlusion (PAOP) ≤ 15 mm Hg,
- Has given his free and informed consent.
Key exclusion criteria (14 listed)
- Minor (age <18 years)
- PAH patients whose diagnosis was there more than 6 months (prevalent cases),
- Patient with PAH associated with concomitant disease (autoimmune disease, portal hypertension, HIV infection, congenital heart disease, schistosomiasis, chronic hemolytic anemia)
- Patient with veno-occlusive disease and / or pulmonary capillary hemangiomatosis suspected or documented
- Patients with pulmonary hypertension associated with left heart (pulmonary hypertension post-capillary)
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 |
|---|---|---|
| Right Heart Catheterizationall patients of the all centers will have Right Heart Catheterization at the diagnosis | Procedure or surgery | pulmonary hypertension |
Primary outcome
death frequency
Time frame: 12 months
1 secondary outcome
death frequency
Time frame: Evolution between baseline assessment and follow-up.
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 11 Apr 2016.
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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.
Olivier SITBON, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right Heart Catheterization in people with Pulmonary Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in 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 3 inclusion and 14 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 11 Apr 2016. 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 France. 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?
death frequency (time frame: 12 months). 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 11 Apr 2016.