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Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics (EFORT)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Right Heart Catheterization
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring Pulmonary hypertension, Prognostic factors, Idiopathic pulmonary hypertension, Family pulmonary hypertension, use anorectics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hôpital Bicêtre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pulmonary hypertension

Arm Description

cohort of patients with pulmonary hypertension

Outcomes

Primary Outcome Measures

death frequency

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2010
Last Updated
April 8, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01185730
Brief Title
Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics
Acronym
EFORT
Official Title
Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Pulmonary hypertension, Prognostic factors, Idiopathic pulmonary hypertension, Family pulmonary hypertension, use anorectics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pulmonary hypertension
Arm Type
Experimental
Arm Description
cohort of patients with pulmonary hypertension
Intervention Type
Procedure
Intervention Name(s)
Right Heart Catheterization
Intervention Description
all patients of the all centers will have Right Heart Catheterization at the diagnosis
Primary Outcome Measure Information:
Title
death frequency
Time Frame
12 months
Secondary Outcome Measure Information:
Title
death frequency
Description
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
Time Frame
Evolution between baseline assessment and follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier SITBON, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Bicêtre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension, Family or Taking Anorectics

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