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Screening of Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers (DELPHI-2)

This study is currently recruiting participants.
Verified March 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01600898
First received: May 15, 2012
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

In this prospective study, the investigators will implement a systematic screening program and 3-year follow-up in a cohort of asymptomatic BMPR2 mutation carriers. This study is designed to:

  • determine predictive factors (biological, functional, radiological and hemodynamic) of development of PAH
  • monitor these subjects' clinical, functional, biological, echocardiographic and hemodynamic characteristics
  • assess the risk of occurrence of PAH
  • screen patients with PAH at an early stage of disease and offer them an early management
  • constitute a collection of biological samples (0, 12, 24 months follow-up) of asymptomatic BMPR2 mutation carriers.

Condition
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening and Risk Factors of Pulmonary Arterial Hypertension in BMPR2 Mutation Asymptomatic Carriers

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • predictive factors of the occurrence of PAH [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    follow prospectively a cohort of asymptomatic BMPR2 mutation carriers to determine predictive factors of the occurrence of PAH.


Secondary Outcome Measures:
  • Evolution of characteristics of asymptomatic BMPR2 mutation carriers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    monitor these subjects' clinical, functional, biological, echocardiographic and hemodynamic characteristics, assess the risk of occurrence of PAH , screen patients with PAH at an early stage of disease and offer them an early management, constitute a collection of biological samples (0, 12, 24 months follow-up) of asymptomatic BMPR2 mutation carriers.


Estimated Enrollment: 100
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asymptomatic BMPR2 mutation carriers
Asymptomatic BMPR2 mutation carriers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

asymptomatic BMPR2 mutation carriers.

Criteria

Inclusion Criteria:

  • men and women over 18 years old,
  • carriers of a BMPR2 mutation without known PAH,
  • having given his informed consent

Exclusion Criteria:

  • men and women under 18 years old,
  • patients with a known PAH,
  • pregnant women,
  • adults protected,
  • detainees,
  • people in emergencies,
  • people refusing or unable to give informed consent,
  • no affiliation to a regime of social security.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600898

Contacts
Contact: David Montani, MD, PhD +33 (0)-1 45 21 21 21 david.montani@bct.aphp.fr
Contact: Marc Humbert, MD, PhD +33 (0)-1 45 21 7972 marc.humbert@bct.aphp.fr

Locations
France
Davis Montani Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: David Montani, MD, PhD     01 45 21 21 21     david.montani@bct.aphp.fr    
Contact: Marc Humbert, MD, PhD     01 45 21 21 21     marc.humbert@bct.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: David Montani, Md, PhD Assistance-Publique Hôpitaux de Paris, Hôpital Bicêtre, Service de pneumologie
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01600898     History of Changes
Other Study ID Numbers: P100104, AOM 10175
Study First Received: May 15, 2012
Last Updated: March 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Asymptomatic carriers of a BMPR2 mutation
follow up study

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
 Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013