Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension

NCT05340023 | Recruiting

• 2 other identifiers: 21CH115ANSM
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Pulmonary hypertension;; chronic thromboembolic pulmonary hypertension; pulmonary embolism; proteomic pattern

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Analysis of recording of hemodynamic data at diagnosis

  Day: 0

• Analysis of recording of hemodynamic data at diagnosis

  Day: 0

• Analysis of recording of hemodynamic data at diagnosis

  Day: 0

• Analysis of recording of hemodynamic data at diagnosis

  Day: 0

• Analysis of recording of hemodynamic after 6 months of treatment

  6 months

Study Arms (1)

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

Interventions

blood sample BIOLOGICAL

to realize proteomic analysis.

Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42055, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample will be realized to proteomic analysis.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Embolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Embolism; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurent BERTOLETTI, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent BERTOLETTI, MD PhD

CONTACT

(0)477127770; laurent.bertoletti@chu-st-etienne.fr

Carine LABRUYERE

CONTACT

(0)477120826; carine.labruyere@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: April 21, 2022
• Study Start: November 9, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)