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NCT Number: NCT03719027

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study population

Diagnostic Test

Dyspnea assessment (NYHA functional class) EKG Echocardiography

Primary outcomes

  1. Cumulated incidence of CTEPH

    Time frame: 30-day +/- 15 days after inclusion visit

    Cumulated incidence rate of CTEPH after pulmonary embolism

Secondary outcomes

  1. Cumulated incidence of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis

    Time frame: 30-day +/- 15 days after inclusion visit

    Cumulated incidence rate of CTEPH in patients without previous signs of CTEPH at the time of index PE diagnosis

  2. Cumulated incidence of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis

    Time frame: 30-day +/- 15 days after inclusion visit

    Cumulated incidence rate of CTEPH in patients with previous signs of CTEPH at the time of index PE diagnosis

  3. Risk factors of CTEPH

    Time frame: 30-day +/- 15 days after inclusion visit

    Hazard ratio of risk factors independently and significantly associated with the diagnosis of CTEPH after pulmonary embolism

  4. Complications associated with right heart catheterization

    Time frame: 30-day +/- 15 days after inclusion visit

    Complication rate of right heart catheterization

  5. Complications associated with pulmonary angiography

    Time frame: 30-day +/- 15 days after inclusion visit

    Complication rate of pulmonary angiography

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: Preva-CTEPH

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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