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

This study is currently recruiting participants.
Verified April 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01185730
First received: August 5, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention
Pulmonary Hypertension
 Procedure: Right Heart Catheterization

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • death frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • death frequency [ Time Frame: Evolution between baseline assessment and follow-up. ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Right Heart Catheterization

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185730

Contacts
Contact: Olivier SITBON, MD, PhD +33(0)-1 4537 4779 olivier.sitbon@abc.aphp.fr

Locations
France
Hôpital Bicêtre Recruiting
Le Kremlin Bicetre, France, 94275
Contact: Olivier SITBON, MD, PhD     +33(0)-1 4521 7983     olivier.sitbon@bct.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Olivier SITBON, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01185730     History of Changes
Other Study ID Numbers: AOM 09065
Study First Received: August 5, 2010
Last Updated: April 3, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary hypertension
Prognostic factors
Idiopathic pulmonary hypertension
Family pulmonary hypertension
use anorectics

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013