Informations générales (source: ClinicalTrials.gov)
Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation (PRINCEPT)
Interventional
N/A
Centre Chirurgical Marie Lannelongue (Voir sur ClinicalTrials)
août 2017
juillet 2020
29 juin 2024
Right heart failure is the main cause of morbi-mortality in patients with pulmonary
hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension
(CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Endarterectomy is an
effective treatment for patients with CTEPH to lower pulmonary pressure. Evidence of
postoperative right heart remodeling are contrasted according to the studies and
determinants of right heart failure are still unclear. Similarly, few evidence exists on
right ventricular remodeling after bilateral lung transplantation for patients with
pulmonary arterial hypertension (PAH). Recent evidence have supported the role of
inflammation and immunity in the pathophysiology of PAH . While several cytokines have
been shown to predict survival , little is known on the implication of inflammation and
immunity in postoperative Right Ventricular failure in patients with PAH.
• The specific translational goal of this current project is to elucidate the role of
immune biomarkers in 6 months postoperative right heart adverse remodeling in patients
with CTEPH or PAH. We speculate that selected immune biomarkers (such as CXCL9,
interleukin -18 or interferon) and growth factors (such as HGF) are correlated with
mid-term postoperative right heart failure.
All consecutive adults with either CTEPH referred to our center for endarterectomy, or
PAH referred for lung transplantation, will be included, aiming for 150 CTEPH and 50 PAH.
After inclusion, patients will undergo assessment of right heart dimensions and function
by cardiac magnetic resonance imaging (MRI, including 4-Dimensions blood flow sequences)
and 2D and 3D trans-thoracic echocardiography (TTE), as well as immune panel analysis.
All patients will undergo as part of routine care right heart catheterization within a
week after TTE and MRI imaging. On the day of surgery, pulmonary pressure will be
measured by right heart catheterization monitoring (as part of routine care) in order to
estimate the drop of pressure and to adjust for the extent of endarterectomy for patients
with CTEPH. TTE will also be performed on the day of surgery if possible. At 7 days
post-endarterectomy or transplant, clinical outcomes will be collected and peripheral
blood will be collected. Patients will be prospectively follow-up for 6 months. Death,
need for reintervention, duration of vasopressor after surgery and number, duration and
cause of readmission will be recorded. At 6 months after surgery, all survivors will
undergo the same biological sampling, as well as an 4D MRI and a 2D and 3D TTE. Data of
right heart catheterization at 6 months (as part of routine care) will be collected as
well.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL MARIE LANNELONGUE | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- adults (age > 18 years old)
- who give their informed consent for the protocol
- with either CTEPH referred to our insitution for pulmonary arterial endarterectomy.
CTEPH is defined by invasive mean pulmonary arterial pressure ≥ 25mmHg at rest,
secondary to chronic pulmonary embolism confirmed by computed tomographic (CT)
angiography and/or ventilation/perfusion scan, according to the lastest guidelines
- Or with PAH referred to our institution for lung transplant. PAH is defined
according to the latest guidelines by an invasive mean pulmonary arterial pressure ≥
25mmHg, secondary to idiopathic, familial, drug or toxin, or connective tissue
disease etiology.
- adults (age > 18 years old)
- who give their informed consent for the protocol
- with either CTEPH referred to our insitution for pulmonary arterial endarterectomy.
CTEPH is defined by invasive mean pulmonary arterial pressure ≥ 25mmHg at rest,
secondary to chronic pulmonary embolism confirmed by computed tomographic (CT)
angiography and/or ventilation/perfusion scan, according to the lastest guidelines
- Or with PAH referred to our institution for lung transplant. PAH is defined
according to the latest guidelines by an invasive mean pulmonary arterial pressure ≥
25mmHg, secondary to idiopathic, familial, drug or toxin, or connective tissue
disease etiology.
- pregnant women
- children
- congenital heart diseases
- contraindications for MRI such as metallic foreign bodies or devices, claustrophobia
- contraindication for surgery
- patients requiring preoperative mechanical assistance such as extracorporeal
membrane oxygenation
- patients with pulmonary arterial sarcoma