Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05340023
Other study ID # 21CH115
Secondary ID ANSM
Status Recruiting
Phase
First received
Last updated
Start date November 9, 2022
Est. completion date December 2025

Study information

Verified date November 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Laurent BERTOLETTI, MD PhD
Phone (0)477127770
Email laurent.bertoletti@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
blood sample
to realize proteomic analysis.

Locations

Country Name City State
France CHU de SAINT-ETIENNE Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Analysis of recording of hemodynamic data at diagnosis hemodynamic data : pulmonary vascular resistance, cardiac index, pulmonary arterial pressures Day: 0
Secondary Analysis of recording of hemodynamic data at diagnosis hemodynamic data : pulmonary vascular resistance, Day: 0
Secondary Analysis of recording of hemodynamic data at diagnosis hemodynamic data : cardiac index Day: 0
Secondary Analysis of recording of hemodynamic data at diagnosis hemodynamic data : pulmonary arterial pressures Day: 0
Secondary Analysis of recording of hemodynamic after 6 months of treatment hemodynamic data : pulmonary vascular resistance, 6 months
Secondary Analysis of recording of hemodynamic after 6 months of treatment hemodynamic data : cardiac index 6 months
Secondary Analysis of recording of hemodynamic data at diagnosis and at death hemodynamic data : pulmonary arterial pressures 6 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06003244 - High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT) N/A
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Active, not recruiting NCT06072417 - HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level) N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Recruiting NCT02061787 - the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
Not yet recruiting NCT03102294 - Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension N/A
Recruiting NCT04071327 - Pulmonary Hypertension Association Registry
Completed NCT00313222 - Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension Phase 3
Recruiting NCT05311072 - Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Database in China
Enrolling by invitation NCT05568927 - Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
Completed NCT03786367 - Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
Recruiting NCT04081012 - N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension. N/A
Not yet recruiting NCT06384534 - Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) N/A
Withdrawn NCT05693779 - Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension N/A
Not yet recruiting NCT02426203 - 3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy N/A
Completed NCT02094001 - Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH Phase 2
Enrolling by invitation NCT03388476 - Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
Recruiting NCT04206852 - Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Completed NCT02111980 - RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators N/A
Enrolling by invitation NCT05618093 - Non-Invasive Measurement of Cardiac Output and Stroke Volume in PAH/CTEPH N/A