Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05340023
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laurent BERTOLETTI, PhD
Principal Investigator Affiliation Centre Hospitalier Universitaire de Saint Etienne
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Thromboembolic Pulmonary Hypertension
Additional Details

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).

Arms & Interventions

Arms

: 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

Interventions

Biological: - blood sample

to realize proteomic analysis.

Contact a Trial Team

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International Sites

CHU de SAINT-ETIENNE, Saint-Étienne, France

Status

Recruiting

Address

CHU de SAINT-ETIENNE

Saint-Étienne, , 42055

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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