NCT01185730

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

March 1, 2016

Enrollment Period

5 years

First QC Date

August 5, 2010

Last Update Submit

April 8, 2016

Conditions

Pulmonary Hypertension

Keywords

Pulmonary hypertensionPrognostic factorsIdiopathic pulmonary hypertensionFamily pulmonary hypertensionuse anorectics

Outcome Measures

Primary Outcomes (1)

  • death frequency

    12 months

Secondary Outcomes (1)

  • death frequency

    Evolution between baseline assessment and follow-up.

Study Arms (1)

pulmonary hypertension

EXPERIMENTAL

cohort of patients with pulmonary hypertension

Procedure: Right Heart Catheterization

Interventions

Right Heart CatheterizationPROCEDURE

all patients of the all centers will have Right Heart Catheterization at the diagnosis

pulmonary hypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Hypertension, PulmonaryFamilial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier SITBON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 20, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-03

Locations

FR(1)