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The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging (MVD)

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ClinicalTrials.gov Identifier: NCT03199131
Recruitment Status : Active, not recruiting
First Posted : June 26, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief Summary:
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.

Condition or disease Intervention/treatment Phase
Chronic Thromboembolic Pulmonary Hypertension Procedure: Right ventricular biopsies Not Applicable

Detailed Description:
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage. As right heart failure is the primary outcome determinant in patients with pulmonary hypertension, understanding the major mediators of RV compensation, failure and recovery is essential to improving patient survival. Recently, there have been significant advances in the ability to assess RV function in vivo using functional imaging techniques, including positron emission tomography (PET) and cardiac MRI (CMR). CMR is an established and validated method of precisely defining cardiac structure and function, and new PET protocols have been developed that measure glucose utilization, oxygen consumption, apoptosis and angiogenesis. Importantly, the in vivo nature of PET and CMR allow for the non-invasive collection of detailed structural, metabolic and physiologic data on the performance of the RV5. When taken in combination with established echocardiographic evaluation, these new platforms allow in-depth analysis of cardiac structure and function without the need for invasive procedures. In order to maximize the potential of these techniques, however, a molecular imaging target needs to be identified so as to allow physicians to detect the transition from a compensated to decompensated state. Such a marker has not yet been reported

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : November 20, 2017
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: CTEPH
Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).
Procedure: Right ventricular biopsies
a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).

Control group
Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension.
Procedure: Right ventricular biopsies
a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).




Primary Outcome Measures :
  1. relationship between the metabolic, morphologic and functional alterations in the right ventricle [ Time Frame: to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery. ]

Secondary Outcome Measures :
  1. validation in human subjects of metabolic signaling pathway alterations found in animal model [ Time Frame: analyse gene and protein expression during surgery ]


Information from the National Library of Medicine

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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:

Chronic thromboembolic pulmonary hypertension group:

  • Patients undergoing pulmonary endarterectomy at Marie Lannelongue Surgical Center for the treatment of chronic thromboembolic pulmonary hypertension.

Control group:

  • Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension on preoperative assessment
  • Exclusion Criteria:

Chronic thromboembolic pulmonary hypertension group:

  • Insufficient biopsy material,
  • pre-operative therapy with bosentan or sildenafil

Control group:

  • Insufficient biopsy sample,
  • ischemic cardiomyopathy,
  • miral or tricuspid valve disease,
  • pre-operative pulmonary hypertension.

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): NCT03199131


Locations
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France
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
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Principal Investigator: Olaf Mercier, MD, PhD Marie Lannelongue Hospital

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03199131     History of Changes
Other Study ID Numbers: 2015-A00149-40
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
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
Lung Diseases
Respiratory Tract Diseases