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Trial record 1 of 6 for:    OLAF MERCIER
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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

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE August 9, 2017
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determinants of Right Heart Remodeling in Patients With CTEPH or PAH
Official Title  ICMJE Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: CTEPH PATIENTS
    Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).
    Interventions:
    • Radiation: magnetic resonance imaging
    • Procedure: 2D and 3D trans-thoracic echocardiography
    • Other: Blood samples
  • Experimental: PAH PATIENTS
    patients with pulmonary arterial hypertension (PAH) undergoing lung transplantation
    Interventions:
    • Radiation: magnetic resonance imaging
    • Procedure: 2D and 3D trans-thoracic echocardiography
    • Other: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03205085
Other Study ID Numbers  ICMJE 2017-A00785-48
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Chirurgical Marie Lannelongue
Study Sponsor  ICMJE Centre Chirurgical Marie Lannelongue
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Chirurgical Marie Lannelongue
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP