Screening of Pulmonary Arterial Hypertension in BMPR2 Mutation Carriers (DELPHI-2)
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ClinicalTrials.gov Identifier: NCT01600898 |
Recruitment Status :
Completed
First Posted : May 17, 2012
Last Update Posted : January 13, 2021
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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 or disease |
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Pulmonary Arterial Hypertension |

Study Type : | Observational |
Actual Enrollment : | 55 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Screening and Risk Factors of Pulmonary Arterial Hypertension in BMPR2 Mutation Asymptomatic Carriers |
Study Start Date : | March 2012 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | July 2016 |

Group/Cohort |
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Asymptomatic BMPR2 mutation carriers
Asymptomatic BMPR2 mutation carriers
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- predictive factors of the occurrence of PAH [ Time Frame: 2 years ]follow prospectively a cohort of asymptomatic BMPR2 mutation carriers to determine predictive factors of the occurrence of PAH.
- Evolution of characteristics of asymptomatic BMPR2 mutation carriers [ Time Frame: 2 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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
France | |
David Montani | |
Le Kremlin-Bicêtre, France, 94270 |
Principal Investigator: | David Montani, Md, PhD | Assistance-Publique Hôpitaux de Paris, Hôpital Bicêtre, Service de pneumologie |
Publications of Results:
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01600898 |
Other Study ID Numbers: |
P100104 AOM 10175 ( Other Identifier: PHRC 2010 ) |
First Posted: | May 17, 2012 Key Record Dates |
Last Update Posted: | January 13, 2021 |
Last Verified: | November 2019 |
Asymptomatic carriers of a BMPR2 mutation follow up study |
Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |