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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01600898
First received: May 15, 2012
Last updated: September 28, 2016
Last verified: September 2016
  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:


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.


Enrollment: 57
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600898

Locations
France
David Montani
Le Kremlin-Bicêtre, France, 94270
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

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: September 28, 2016
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
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2016