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Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) and Rubidium-82 (82Rb) Positron Emission Tomography/Computed Tomography (PET/CTs) on Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

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ClinicalTrials.gov Identifier: NCT02970851
Recruitment Status : Unknown
Verified November 2016 by John O. Prior, University of Lausanne Hospitals.
Recruitment status was:  Recruiting
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals

Brief Summary:

The purpose of this study is to assess the effect of bosentan on the myocardial metabolism and the dependent endothelial coronary vasomotoricity in patients presenting a PAH.

Hypothesis : Bosentan may improve right ventricular function by decreasing myocardial stress and glucose metabolism. Patients may benefit from images with 18F-FDG PET / CT and 82Rb PET / CT for an earlier assessment and optimal management of PAH.


Condition or disease
Myocardial Dysfunction Endothelial Dysfunction

Detailed Description:

Patients refered to the hospital for a right heart catheterization for a PAH suspected at the echocardiography will be presented with the protocol.If inclusion/exclusion criteria are fulfilled all the procedures will be planned. At the screening visit the patient will have a right heart catheterization and an echocardiography. After a maximum of 4 weeks each patient will have 18F-FDG and 82Rb PET/CTs before start of treatment with Bosentan. These PET/CTs together with an echocardiography will be repeated at 6 and 12 weeks after start of treatment with bosentan.

Finally a right heart catheterization will be planned at 12 weeks after start of treatment with bosentan as a routine procedure.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Endothelin Receptor Antagonist Bosentan in Glucose Metabolism of the Myocardium and Coronary Dependant Endothelial Vasoreactivity Measured by 18F-FDG PET / CT and 82Rb PET / CT in Patients With PAH or CTEPH
Study Start Date : April 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019





Primary Outcome Measures :
  1. Analysis of each method of imaging for assessment of myocardial metabolism [ Time Frame: Baseline ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

  2. Analysis of each method of imaging for assessment of myocardial metabolism [ Time Frame: at 4 weeks after start of treatment ]
    myocardial ventricular right maximum standardized uptake value (SUVmax) on the images of au 18F-FDG PET/CT

  3. Analysis of each method of imaging for assessment of myocardial metabolism [ Time Frame: at 6 weeks after start of treatment ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

  4. Analysis of each method of imaging for assessment of myocardial metabolism [ Time Frame: at 12 weeks after start of treatment ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

  5. On the images 82Rb PET/CT rest MBF [ Time Frame: Baseline ]
    myocardial blood flow (MBF in mL/min/g) at rest

  6. On the images 82Rb PET/CT rest MBF [ Time Frame: at 4 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at rest

  7. On the images 82Rb PET/CT rest MBF [ Time Frame: at 6 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at rest

  8. On the images 82Rb PET/CT rest MBF [ Time Frame: at 12 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at rest

  9. On the images 82Rb PET/CT stress MBF [ Time Frame: Baseline ]
    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

  10. On the images 82Rb PET/CT stress MBF [ Time Frame: at 4 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

  11. On the images 82Rb PET/CT stress MBF [ Time Frame: at 6 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

  12. On the images 82Rb PET/CT stress MBF [ Time Frame: at 12 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

  13. On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF [ Time Frame: Baseline ]
    myocardial blood flow (MBF in mL/min/g) at cold test

  14. On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF [ Time Frame: at 4 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at cold test

  15. On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF [ Time Frame: at 6 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at cold test

  16. On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF [ Time Frame: at 12 weeks after start of treatment ]
    myocardial blood flow (MBF in mL/min/g) at cold test

  17. Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction [ Time Frame: Baseline ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

  18. Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction [ Time Frame: at 4 weeks after start of treatment ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

  19. Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction [ Time Frame: at 6 weeks after start of treatment ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

  20. Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction [ Time Frame: at 12 weeks after start of treatment ]
    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)


Secondary Outcome Measures :
  1. Analysis of right heart catheterization parameters PAP [ Time Frame: at screening ]
    pulmonary arterial pressure (PAP)

  2. Analysis of right heart catheterization parameters PAP [ Time Frame: at 12 weeks after start of treatment ]
    PAP

  3. Analysis of right heart catheterization parameters RAP [ Time Frame: at screening ]
    right atrial pressure (RAP)

  4. Analysis of right heart catheterization parameters RAP [ Time Frame: at 12 weeks after start of treatment ]
    RAP

  5. Analysis of right heart catheterization parameters PWP [ Time Frame: at screening ]
    pulmonary wedge pressure (PWP)

  6. Analysis of right heart catheterization parameters PWP [ Time Frame: at 12 weeks after start of treatment ]
    PWP

  7. Analysis of clinical parameters NYHA [ Time Frame: at screening ]
    NYHA classification

  8. Analysis of clinical parameters NYHA [ Time Frame: at 12 weeks after start of treatment ]
    New York Heart Association (NYHA) classification

  9. Analysis of clinical parameters 6-min walk test [ Time Frame: at screening ]
    6-minute walk test

  10. Analysis of clinical parameters 6-min walk test [ Time Frame: at 12 weeks after start of treatment ]
    6-minute walk test

  11. Analysis of clinical parameters LFT [ Time Frame: at screening ]
    Results of lung function tests

  12. Analysis of clinical parameters LFT [ Time Frame: at 12 weeks after start of treatment ]
    Results of lung function tests

  13. Analysis of clinical parameters NT-pro-BNP [ Time Frame: at screening ]
    plasmatic N terminal - pro - Brain Natriuretic Peptide (NT-pro-BNP)

  14. Analysis of clinical parameters NT-pro-BNP [ Time Frame: at 12 weeks after start of treatment ]
    plasmatic NT-pro-BNP



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for Bosentan therapy
Criteria

Inclusion Criteria:

  • Patients with chronic PAH (PH group 1 Dana Point / stages 2 à 4 according to NYHA classification, defined by a mean arterial pulmonary pressure >25 millimeter of mercury (mmHg) at rest, an occlusion arterial pulmonary pressure <15 millimeter of mercury (mmHg) and vascular pulmonary resistance >240 dyn.s.cm-5 for which a treatment with bosentan is indicated Or Patients with CTEPH not candidate for a pulmonary endarterectomy or patient with residual CTEPH after pulmonary endarterectomy (PH group 4 Dana Point / stages 2 to 4 according to NYHA classification) and for which a treatment with bosentan is indicated
  • Indication to perform a right heart catheterization in the context of PAH suspected during cardiac ultrasound
  • Age from 18 to 80 years old, male and female
  • Karnofsky index ≥80%
  • Informed consent signed

Exclusion Criteria:

  • Patients with PAH stages 2,3 or 5 of Dana Point
  • Patients with a contra-indication to adenosine including severe uncontrolled asthma, severe uncontrolled chronic obstructive pulmonary disease, 2nd or 3rd degree atrioventricular block without pacemaker,
  • Patients with a contraindication to Bosentan, i.e :hypersensibility to the product, hepatic failure Child Pugh B or C, aminotransferases >3 times normal value (N),association with cyclosporine A or glibenclamide
  • Pregnancy, female of child-bearing potential not using any acceptable contraceptive method, breastfeeding
  • Atrial fibrillation (Ventricular Ejection Fraction (VEF) not evaluable at echography)
  • Karnofsky index <80%
  • Impossibility to obtain informed consent signed
  • Left cardiopathies that can be responsible of post-capillar hypertension
  • Involvement in another clinical study with an unregistered drug within 30 days prior to this specific study and during the entire course of the study
  • Inability to comply with study procedures (linguistic problem, psychiatric problems, dementia, confusional state)
  • Known or suspected non compliance drug or alcohol abuse
  • Left heart assessment : diastolic and systolic function and valvular structures to exclude a cardiac pathology

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): NCT02970851


Contacts
Layout table for location contacts
Contact: John O Prior, MD,PhD +41 21 314 43 48 john.prior@chuv.ch
Contact: Christine Geldhof +41213144346 christine.geldhof@chuv.ch

Locations
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Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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Principal Investigator: John O Prior, MD PhD Lausanne University Hospitals

Layout table for additonal information
Responsible Party: John O. Prior, Chief of the Department of Nuclear medicine, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT02970851    
Other Study ID Numbers: 08/12
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John O. Prior, University of Lausanne Hospitals:
Endothelin receptor antagonist (ERA)
pulmonary artery hypertension (PAH),
18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT)
Rubidium-82 (82Rb) PET/CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Deoxyglucose
Bosentan
Fluorodeoxyglucose F18
Endothelin Receptor Antagonists
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Antimetabolites
Antiviral Agents
Anti-Infective Agents