Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.

HTPPE Clinical Trial

— PADIS-HTP  

Official title:

Frequency and Risk Factors of the Lung High Blood Pressure Post-embolique in the Fall of a First Episode of Idiopathic Pulmonary Embolism. Study " PADIS HTP "

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01894204
• Other study ID #: RB 12.161 - PADIS HTP
• Status: Terminated
• Phase: N/A
• Start date: June 27, 2013
• Est. completion date: May 29, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Forward-looking troop established(constituted) by the patients having been included in the study " PADIS EP ", PHRC on 2006 and 2009, randomized checked(controlled), double-blind, comparing an anticoagulating treatment(processing) extended by coumadine versus placebo during 18 months at patients having had a first episode of EP idiopathique treated(handled) initially 6 months by anti-vitamin K.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 235
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.

Exclusion Criteria:

• Refusal to grant in writing to participate in the study PADIS HTP

Related Conditions & MeSH terms

• Embolism
• HTPPE
• Idiopathic Pulmonary Embolism
• Pulmonary Embolism

Intervention

Other:
• HTPPE
No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CH de Lannion	Lannion
France	Hôpital Européen Georges Pompidou	Paris cedex 15
France	CHU Pontchaillou - Hôpital Sud	Rennes
France	Hôpital Yves Le Foll	Saint-Brieuc
France	Hôpital de Bellevue - CHU de Saint-Etienne	Saint-Etienne
France	Hôpital Rangueuil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of a HTPPE		24 months
Secondary	Mortality and cause		24 months