Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension

Recruiting

• Conditions: Chronic Thromboembolic Pulmonary Hypertension
• Interventions: Biological: blood sample

• Registration Number: NCT05340023
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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).

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 Timeline

• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-21
• Study Start: 2022-11-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with suspicion of Chronic ThromboEmbolic Pulmonary Hypertension (CTEPH)	blood sample	* 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

Primary Outcome Measures

Name	Time	Method
Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH)	Day: 0	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).

Secondary Outcome Measures

Name	Time	Method
Analysis of recording of hemodynamic data at diagnosis	Day: 0	hemodynamic data : pulmonary arterial pressures
Analysis of recording of hemodynamic data at diagnosis and at death	6 months	hemodynamic data : pulmonary arterial pressures
Analysis of recording of hemodynamic after 6 months of treatment	6 months	hemodynamic data : cardiac index

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-Étienne, France