Clinical trial NCT03719027: Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)
Official title: Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Pulmonary Embolism
Keywords: Prevalence and incidence of CTEPH after pulmonary embolism
history of diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-10-25
Enrollment: 2003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Retrospective and prospective cohort study
Primary purpose: DIAGNOSTIC

Brief summary: The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.

The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.

Detailed description: The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network.

Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA \>1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines.

Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase.

For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved.

All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Pulmonary embolism objectively confirmed
* Treated during at least 3 months with curative anticoagulant
* Previously included since at least 1 year in one of the studies of the INNOVTE network
* affiliated to the national social security
* after written informed consent

Exclusion Criteria:

* Patients with an objectively confirmed CTEPH before the diagnosis of index PE
* Follow-up impossible

Primary outcomes:
measure: Cumulated incidence of CTEPH
timeFrame: 30-day +/- 15 days after inclusion visit
Secondary outcomes:
measure: Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis
timeFrame: 30-day +/- 15 days after inclusion visit
measure: Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis
timeFrame: 30-day +/- 15 days after inclusion visit
measure: Risk factors of CTEPH
timeFrame: 30-day +/- 15 days after inclusion visit
measure: Complications associated with right heart catheterization
timeFrame: 30-day +/- 15 days after inclusion visit
measure: Complications associated with pulmonary angiography
timeFrame: 30-day +/- 15 days after inclusion visit
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Brest
country: France
facility: La Cavale Blanche
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou
city: Saint-Étienne
country: France
facility: Hôpital Nord
Study officials:
affiliation: Université Paris Descartes
name: Olivier SANCHEZ, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guerin L, Couturaud F, Parent F, Revel MP, Gillaizeau F, Planquette B, Pontal D, Guegan M, Simonneau G, Meyer G, Sanchez O. Prevalence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism. Prevalence of CTEPH after pulmonary embolism. Thromb Haemost. 2014 Sep 2;112(3):598-605. doi: 10.1160/TH13-07-0538. Epub 2014 Jun 5.
citation: Ende-Verhaar YM, Cannegieter SC, Vonk Noordegraaf A, Delcroix M, Pruszczyk P, Mairuhu AT, Huisman MV, Klok FA. Incidence of chronic thromboembolic pulmonary hypertension after acute pulmonary embolism: a contemporary view of the published literature. Eur Respir J. 2017 Feb 23;49(2):1601792. doi: 10.1183/13993003.01792-2016. Print 2017 Feb.