Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01185730
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2010-08-05
Brief Title:
Prospective Longitudinal Study of Patients With Idiopathic Pulmonary Arterial Hypertension Family or Taking Anorectics
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Prognostic Factors and Therapeutic Targets in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFORT
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None