Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics (EFORT)
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ClinicalTrials.gov Identifier: NCT01185730 |
Recruitment Status :
Completed
First Posted : August 20, 2010
Last Update Posted : April 11, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension | Procedure: Right Heart Catheterization | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 165 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: pulmonary hypertension
cohort of patients with pulmonary hypertension
|
Procedure: Right Heart Catheterization
all patients of the all centers will have Right Heart Catheterization at the diagnosis |
- death frequency [ Time Frame: 12 months ]
- death frequency [ Time Frame: Evolution between baseline assessment and follow-up. ]
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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
Exclusion criteria:
- 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)
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185730
France | |
Hôpital Bicêtre | |
Le Kremlin Bicetre, France, 94275 |
Principal Investigator: | Olivier SITBON, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01185730 |
Other Study ID Numbers: |
AOM 09065 |
First Posted: | August 20, 2010 Key Record Dates |
Last Update Posted: | April 11, 2016 |
Last Verified: | March 2016 |
Pulmonary hypertension Prognostic factors Idiopathic pulmonary hypertension Family pulmonary hypertension use anorectics |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |