NCT02970851

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

5.8 years

First QC Date

June 19, 2016

Last Update Submit

March 18, 2020

Conditions

Myocardial DysfunctionEndothelial Dysfunction

Keywords

Endothelin receptor antagonist (ERA)pulmonary artery hypertension (PAH),18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CTRubidium-82 (82Rb) PET/CT

Outcome Measures

Primary Outcomes (20)

  • Analysis of each method of imaging for assessment of myocardial metabolism

    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

    Baseline

  • Analysis of each method of imaging for assessment of myocardial metabolism

    myocardial ventricular right maximum standardized uptake value (SUVmax) on the images of au 18F-FDG PET/CT

    at 4 weeks after start of treatment

  • Analysis of each method of imaging for assessment of myocardial metabolism

    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

    at 6 weeks after start of treatment

  • Analysis of each method of imaging for assessment of myocardial metabolism

    On the images of au 18F-FDG PET/CT : myocardial ventricular right maximum standardized uptake value (SUVmax)

    at 12 weeks after start of treatment

  • On the images 82Rb PET/CT rest MBF

    myocardial blood flow (MBF in mL/min/g) at rest

    Baseline

  • On the images 82Rb PET/CT rest MBF

    myocardial blood flow (MBF in mL/min/g) at rest

    at 4 weeks after start of treatment

  • On the images 82Rb PET/CT rest MBF

    myocardial blood flow (MBF in mL/min/g) at rest

    at 6 weeks after start of treatment

  • On the images 82Rb PET/CT rest MBF

    myocardial blood flow (MBF in mL/min/g) at rest

    at 12 weeks after start of treatment

  • On the images 82Rb PET/CT stress MBF

    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

    Baseline

  • On the images 82Rb PET/CT stress MBF

    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

    at 4 weeks after start of treatment

  • On the images 82Rb PET/CT stress MBF

    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

    at 6 weeks after start of treatment

  • On the images 82Rb PET/CT stress MBF

    myocardial blood flow (MBF in mL/min/g) at pharmacological stress

    at 12 weeks after start of treatment

  • On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF

    myocardial blood flow (MBF in mL/min/g) at cold test

    Baseline

  • On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF

    myocardial blood flow (MBF in mL/min/g) at cold test

    at 4 weeks after start of treatment

  • On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF

    myocardial blood flow (MBF in mL/min/g) at cold test

    at 6 weeks after start of treatment

  • On the images 82Rb PET/CT, analysis of endothelial dysfunction cold test MBF

    myocardial blood flow (MBF in mL/min/g) at cold test

    at 12 weeks after start of treatment

  • Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction

    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

    Baseline

  • Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction

    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

    at 4 weeks after start of treatment

  • Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction

    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

    at 6 weeks after start of treatment

  • Analysis of each method of imaging for assessment of myocardial metabolism and endothelial dysfunction

    On the images of au 18F-FDG PET/CT : myocardial ventricular left maximum standardized uptake value (SUVmax)

    at 12 weeks after start of treatment

Secondary Outcomes (14)

  • Analysis of right heart catheterization parameters PAP

    at screening

  • Analysis of right heart catheterization parameters PAP

    at 12 weeks after start of treatment

  • Analysis of right heart catheterization parameters RAP

    at screening

  • Analysis of right heart catheterization parameters RAP

    at 12 weeks after start of treatment

  • Analysis of right heart catheterization parameters PWP

    at screening

  • +9 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for Bosentan therapy

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Links

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • John O Prior, MD PhD

    Lausanne University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Department of Nuclear medicine

Study Record Dates

First Submitted

June 19, 2016

First Posted

November 22, 2016

Study Start

April 1, 2013

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)