Clinical trial NCT05340023: Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
Official title: Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension : PROTEO-CTEPH Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
Keywords: Pulmonary hypertension;
chronic thromboembolic pulmonary hypertension
pulmonary embolism
proteomic pattern
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proteomic pattern associated with the diagnosis of Chronic thromboembolic pulmonary hypertension (CTEPH)
timeFrame: Day: 0
Secondary outcomes:
measure: Analysis of recording of hemodynamic data at diagnosis
timeFrame: Day: 0
measure: Analysis of recording of hemodynamic data at diagnosis
timeFrame: Day: 0
measure: Analysis of recording of hemodynamic data at diagnosis
timeFrame: Day: 0
measure: Analysis of recording of hemodynamic data at diagnosis
timeFrame: Day: 0
measure: Analysis of recording of hemodynamic after 6 months of treatment
timeFrame: 6 months
measure: Analysis of recording of hemodynamic after 6 months of treatment
timeFrame: 6 months
measure: Analysis of recording of hemodynamic data at diagnosis and at death
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Laurent BERTOLETTI, PhD
role: PRINCIPAL_INVESTIGATOR
References: