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Determinants of Right Heart Remodeling in Patients With CTEPH or PAH (PRINCEPT)

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ClinicalTrials.gov Identifier: NCT03205085
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension Radiation: magnetic resonance imaging Procedure: 2D and 3D trans-thoracic echocardiography Other: Blood samples Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CTEPH PATIENTS
Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).
 Radiation: magnetic resonance imaging
assessment of right heart dimensions and function by cardiac magnetic resonance Imaging.

Procedure: 2D and 3D trans-thoracic echocardiography
assessment of right heart dimensions and function by 2D and 3D trans-thoracic echocardiography

Other: Blood samples
Blood samples for assays of immune inflammatory biomarkers (InterLeukin-18, CXCL9 or interferon
Experimental: PAH PATIENTS
patients with pulmonary arterial hypertension (PAH) undergoing lung transplantation
 Radiation: magnetic resonance imaging
assessment of right heart dimensions and function by cardiac magnetic resonance Imaging.

Procedure: 2D and 3D trans-thoracic echocardiography
assessment of right heart dimensions and function by 2D and 3D trans-thoracic echocardiography

Other: Blood samples
Blood samples for assays of immune inflammatory biomarkers (InterLeukin-18, CXCL9 or interferon


Outcome Measures
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Primary Outcome Measures :
  1. right ventricular adverse remodeling [ Time Frame: 6 months ]
    postoperative right ventricular adverse remodeling, defined by increase above 10% in end-systolic right ventricular volume indexed on body surface area assessed by cardiac MRI.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205085


Contacts
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Contact: LILIA LAMRANI 01.40.94.25.54 ext 33 l.lamrani@ccml.fr
Contact: OLAF MERCIER 01.40.94.86.95 o.mercier@ccml.fr

Locations
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France
Hopital Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
More Information
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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03205085    
Other Study ID Numbers: 2017-A00785-48
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases