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Determinants of Right Heart Remodeling in Patients With CTEPH or PAH
Recruiting
Trial ID: NCT03205085
Purpose
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.
Official Title
Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation
Eligibility
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.
Exclusion Criteria:
- 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
Intervention(s):
radiation: magnetic resonance imaging
procedure: 2D and 3D trans-thoracic echocardiography
other: Blood samples
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305