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

Pulmonary Embolism Clinical Trial

— Preva-CTEPH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719027
• Other study ID #: K161203J
• Secondary ID: 2017-A02047-46
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: June 29, 2022

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2003
• Est. completion date: June 29, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
• Embolism
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Embolism

Intervention

Diagnostic Test:
• Study population
Dyspnea assessment (NYHA functional class) EKG Echocardiography

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon
France	La Cavale Blanche	Brest
France	Hôpital européen Georges-Pompidou	Paris
France	Hôpital Nord	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View 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 emb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulated incidence of CTEPH	Cumulated incidence rate of CTEPH after pulmonary embolism	30-day +/- 15 days after inclusion visit
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications associated with right heart catheterization	Complication rate of right heart catheterization	30-day +/- 15 days after inclusion visit
Secondary	Complications associated with pulmonary angiography	Complication rate of pulmonary angiography	30-day +/- 15 days after inclusion visit