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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600898
First Posted: May 17, 2012
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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 ]
    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 ]
    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
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asymptomatic BMPR2 mutation carriers
Asymptomatic BMPR2 mutation carriers

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: PHRC 2010 )
First Submitted: May 15, 2012
First Posted: May 17, 2012
Last Update Posted: May 3, 2017
Last Verified: April 2017

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