Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension (PROTEO-CTEPH)

Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension : PROTEO-CTEPH Study.

Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH) is a rare but severe complication of pulmonary embolism (PE). CTEPH is evoked in patients with persistent dyspnea. According to international guidelines, symptomatic patients with perfusion defects on lung scan and Pulmonary Hypertension (PH)-likely transthoracic echo (TTE) must be evaluated in Pulmonary Hypertension (PH)-centers with right heart catheterism, to confirm or rule out the presence of precapillary Pulmonary Hypertension (PH), and precise the group of Pulmonary Hypertension (PH).

Study Overview

• Status: Recruiting
• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Biological: blood sample

Detailed Description

However, persistent dyspnea and perfusion defects are frequent after pulmonary embolism (PE), and the accuracy of transthoracic echo (TTE) is not great for precapillary Pulmonary Hypertension (PH).

This study proposed to seek for a specific proteomic pattern in patients admitted for a suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH).

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Laurent BERTOLETTI, MD PhD; Phone Number: +33 (0)477127770; Email: laurent.bertoletti@chu-st-etienne.fr
• Study Contact Backup: Name: Carine LABRUYERE; Phone Number: +33 (0)477120826; Email: carine.labruyere@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint-Etienne
    • Principal Investigator: Laurent Bertoletti, MD PhD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study will be offered to all consecutive patients admitted to the participating competence centers, provided they meet the the study, provided they meet the inclusion criteria and have no non-inclusion criteria.

Description

Inclusion Criteria:

• Patient with a suspicion of Chronic thromboembolic pulmonary hypertension (CTEPH) with a combination of a perfusion lung scan and transthoracic perfusion scan and transthoracic echocardiography compatible with the diagnosis (according to French recommendations)
• Patients who require a right heart catheterization.
• Patient affiliated or entitled to a social security plan
• Patient having received informed information about the study informed about the study

Exclusion Criteria:

• Patient with a normal perfusion lung scan
• Person under legal guardianship

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH); right cardiac catheterization (usual practice); a blood sample (inclusion for all patients with suspicion); if diagnosis of Chronic thromboembolic pulmonary hypertension confirmed a another bood sample at 6 months	Biological: blood sample; to realize proteomic analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH)	Analysis of the final diagnosis retained for the patient : Chronic thromboembolic pulmonary hypertension (CTEPH) (population of interest), pre-capillary Pulmonary Hypertension (PH) other than Chronic thromboembolic pulmonary hypertension (CTEPH), post-capillary Pulmonary Hypertension (PH), no Pulmonary Hypertension (PH).	Day: 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of recording of hemodynamic data at diagnosis	hemodynamic data : pulmonary vascular resistance, cardiac index, pulmonary arterial pressures	Day: 0
Analysis of recording of hemodynamic data at diagnosis	hemodynamic data : pulmonary vascular resistance,	Day: 0
Analysis of recording of hemodynamic data at diagnosis	hemodynamic data : cardiac index	Day: 0
Analysis of recording of hemodynamic data at diagnosis	hemodynamic data : pulmonary arterial pressures	Day: 0
Analysis of recording of hemodynamic after 6 months of treatment	hemodynamic data : pulmonary vascular resistance,	6 months
Analysis of recording of hemodynamic after 6 months of treatment	hemodynamic data : cardiac index	6 months
Analysis of recording of hemodynamic data at diagnosis and at death	hemodynamic data : pulmonary arterial pressures	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Laurent BERTOLETTI, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pulmonary embolism; chronic thromboembolic pulmonary hypertension; Pulmonary hypertension;; proteomic pattern
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Hypertension; Pulmonary Embolism; Hypertension, Pulmonary; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 21CH115; ANSM (Other Identifier: 2025-A02337-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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