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

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03199131
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Centre Chirurgical Marie Lannelongue
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Olaf Mercier, MD, PhD
Principal Investigator Affiliation	Marie Lannelongue Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Thromboembolic Pulmonary Hypertension

Additional Details

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

Arms & Interventions

Arms

Experimental: CTEPH

Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH).

Other: Control group

Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension.

Interventions

Procedure: - Right ventricular biopsies

a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).

Contact a Trial Team

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International Sites

Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, France

Status

Address

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, , 92350

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