Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH) (Preva-CTEPH)

Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism. History of the Diagnosis. (Preva-CTEPH) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism; Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
• Intervention / Treatment: Diagnostic test: Study population

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier SANCHEZ, MD, PhD; Phone Number: +33156093487; Email: olivier.sanchez@aphp.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU Jean Minjoz
    • Contact: Nicolas MENEVEAU, MD,PhD
  • Brest, France
    • Recruiting
    • La Cavale Blanche
    • Contact: Francis Couturaud, MD,PhD
  • Paris, France, 75015
    • Recruiting
    • Hopital Europeen Georges-Pompidou
    • Contact: Olivier Sanchez, MD,PhD; Phone Number: +33156093487; Email: olivier.sanchez@aphp.fr
  • Saint-Étienne, France
    • Recruiting
    • Hôpital Nord
    • Contact: Laurent BERTOLETTI, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study population; Patients followed-up after the diagnosis of pulmonary embolism (PE) Patients who survived after a PE and who consent to participate to the prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH	Diagnostic test: Study population; Dyspnea assessment (NYHA functional class) EKG Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated incidence of CTEPH	Cumulated incidence rate of CTEPH after pulmonary embolism	30-day +/- 15 days after inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis	Cumulated incidence rate of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis	30-day +/- 15 days after inclusion visit
Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis	Cumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis	30-day +/- 15 days after inclusion visit
Risk factors of CTEPH	Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism	30-day +/- 15 days after inclusion visit
Complications associated with right heart catheterization	Complication rate of right heart catheterization	30-day +/- 15 days after inclusion visit
Complications associated with pulmonary angiography	Complication rate of pulmonary angiography	30-day +/- 15 days after inclusion visit

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Olivier SANCHEZ, MD, PhD, Université Paris Descartes

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Prevalence and incidence of CTEPH after pulmonary embolism; history of diagnosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Hypertension; Embolism; Hypertension, Pulmonary; Pulmonary Embolism
• Other Study ID Numbers: K161203J; 2017-A02047-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Individual patient level meta-analysis for cumulative incidence rate and risk factors of CTEPH after PE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No