HTPPEPADIS-HTPNCT01894204
Determine the Frequency of a HTPPE in 5 Years (± on 1 Year) After a First Episode of Idiopathic Pulmonary Embolism.
A study testing HTPPE in people with HTPPE and Idiopathic Pulmonary Embolism, run by University Hospital, Brest at 8 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTPPE, Idiopathic Pulmonary Embolism
- What is being tested?
- HTPPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 8 sitesFrance
- Study dates
- 27 Jun 2013to 29 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.
Who cannot join
- Refusal to grant in writing to participate in the study PADIS HTP
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHRU de Brest
Brest, 29609
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CH de Lannion
Lannion, 22300
Hôpital Européen Georges Pompidou
Paris, 75908
CHU Pontchaillou - Hôpital Sud
Rennes, 35056
Hôpital Yves Le Foll
Saint-Brieuc, 22027
Hôpital de Bellevue - CHU de Saint-Etienne
Saint-Etienne, 45055
Hôpital Rangueuil
Toulouse, 31059
About this study
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 "
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.
- Conditions
- HTPPE, Idiopathic Pulmonary Embolism
- Being tested
- HTPPE
- Keywords
- HTTPE, Idiopathic Pulmonary embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTPPEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HTPPE | Other | 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. Receives: Other: HTPPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of a HTPPE
Measured: 24 months
Secondary outcomes (1)
Mortality and cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start27 Jun 2013
- Primary completion29 May 2018
- Study completion29 May 2018
Why it stopped: The maximum of inclusions was reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTPPEStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis COUTURAUD, PU-PH, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894204
- Sponsor's protocol ID
- RB 12.161 - PADIS HTP
- Acronym
- PADIS-HTP
- Status last verified
- May 2018
- First submitted
- 28 Jun 2013
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fauche A, Presles E, Sanchez O, Jais X, Le Mao R, Robin P, Pernod G, Bertoletti L, Jego P, Parent F, Lemarie CA, Leven F, Le Roux PY, Salaun PY, Nonent M, Girard P, Lacut K, Savale L, Melac S, Guegan M, Mismetti P, Laporte S, Leroyer C, Montani D, Couturaud F, Tromeur C; PADIS-PE Investigators. Frequency and predictors for chronic thromboembolic pulmonary hypertension after a first unprovoked pulmonary embolism: Results from PADIS studies. J Thromb Haemost. 2022 Dec;20(12):2850-2861. doi: 10.1111/jth.15866. Epub 2022 Sep 25.
PubMed 36017744
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 "
- ClinicalTrials.gov ID
- NCT01894204
- Acronym / sponsor ID
- PADIS-HTP / RB 12.161 - PADIS HTP
- Conditions
- HTPPE, Idiopathic Pulmonary Embolism
- Keywords
- HTTPE, Idiopathic Pulmonary embolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The maximum of inclusions was reached
- Enrolment
- 235 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 27 Jun 2013 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HTPPE | Other | Other: HTPPENo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having ended the study PADIS EP after the visit of the end of study and having signed the consent HTP.
Key exclusion criteria (1 listed)
- Refusal to grant in writing to participate in the study PADIS HTP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HTPPENo 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. | Other | HTPPE |
Primary outcome
Frequency of a HTPPE
Time frame: 24 months
1 secondary outcome
Mortality and cause
Time frame: 24 months
Results and safety
The study was stopped early (reason given: The maximum of inclusions was reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Derived from this study: PubMed 36017744Fauche A, Presles E, Sanchez O, Jais X, Le Mao R, Robin P, Pernod G, Bertoletti L, Jego P, Parent F, Lemarie CA, Leven F, Le Roux PY, Salaun PY, Nonent M, Girard P, Lacut K, Savale L, Melac S, Guegan M, Mismetti P, Laporte S, Leroyer C, Montani D, Couturaud F, Tromeur C; PADIS-PE Investigators. Frequency and predictors for chronic thromboembolic pulmonary hypertension after a first unprovoked pulmonary embolism: Results from PADIS studies. J Thromb Haemost. 2022 Dec;20(12):2850-2861. doi: 10.1111/jth.15866. Epub 2022 Sep 25.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis COUTURAUD, PU-PH principal investigator
CHRU de Brest
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HTPPE in people with HTPPE and Idiopathic Pulmonary Embolism, run by University Hospital, Brest at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The maximum of inclusions was reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of a HTPPE (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.