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

Primary Purpose

HTPPE, Idiopathic Pulmonary Embolism

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HTPPE
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HTPPE focused on measuring HTTPE, Idiopathic Pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU de Brest
  • CHU Clermont-Ferrand
  • CH de Lannion
  • Hôpital Européen Georges Pompidou
  • CHU Pontchaillou - Hôpital Sud
  • Hôpital Yves Le Foll
  • Hôpital de Bellevue - CHU de Saint-Etienne
  • Hôpital Rangueuil

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HTPPE

Arm Description

No drug and no placebo were used in this study. For all the patients who participated at the study PADIS-EP, somme exams must be performed.

Outcomes

Primary Outcome Measures

Frequency of a HTPPE

Secondary Outcome Measures

Mortality and cause

Full Information

First Posted
June 28, 2013
Last Updated
July 19, 2018
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT01894204
Brief Title
Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.
Acronym
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 "
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
The maximum of inclusions was reached
Study Start Date
June 27, 2013 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
May 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HTPPE, Idiopathic Pulmonary Embolism
Keywords
HTTPE, Idiopathic Pulmonary embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HTPPE
Arm Type
Other
Arm Description
No drug and no placebo were used in this study. For all the patients who participated at the study PADIS-EP, somme exams must be performed.
Intervention Type
Other
Intervention Name(s)
HTPPE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of a HTPPE
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mortality and cause
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, PU-PH
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH de Lannion
City
Lannion
ZIP/Postal Code
22300
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
CHU Pontchaillou - Hôpital Sud
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Hôpital Yves Le Foll
City
Saint-Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Hôpital de Bellevue - CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
45055
Country
France
Facility Name
Hôpital Rangueuil
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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