TerminatedNCT02970851Updated Mar 23, 2020

Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH

An observational study in Myocardial Dysfunction and Endothelial Dysfunction, sponsored by University of Lausanne Hospitals. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-03-23.

Sponsored by University of Lausanne Hospitals · Observational

Why this study was terminated

Slow patient recruitment after arrival of macitentan on the market

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Myocardial Dysfunction
Endothelial Dysfunction

Keywords

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

In context

Lead sponsor

University of Lausanne Hospitals is the lead sponsor of 118 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Patients eligible for Bosentan therapy

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

Analysis of right heart catheterization parameters PAP
pulmonary arterial pressure (PAP)
Time frame: at screening
Analysis of right heart catheterization parameters PAP
PAP
Time frame: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters RAP
right atrial pressure (RAP)
Time frame: at screening
Analysis of right heart catheterization parameters RAP
RAP
Time frame: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters PWP
pulmonary wedge pressure (PWP)
Time frame: at screening
Analysis of right heart catheterization parameters PWP
PWP
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters NYHA
NYHA classification
Time frame: at screening
Analysis of clinical parameters NYHA
New York Heart Association (NYHA) classification
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters 6-min walk test
6-minute walk test
Time frame: at screening
Analysis of clinical parameters 6-min walk test
6-minute walk test
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters LFT
Results of lung function tests
Time frame: at screening
Analysis of clinical parameters LFT
Results of lung function tests
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters NT-pro-BNP
plasmatic N terminal - pro - Brain Natriuretic Peptide (NT-pro-BNP)
Time frame: at screening
Analysis of clinical parameters NT-pro-BNP
plasmatic NT-pro-BNP
Time frame: at 12 weeks after start of treatment

Study locations

1 site

Centre Hospitalier Universitaire Vaudois
Lausanne, Vaud 1011, Switzerland

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02970851
Lead sponsor: University of Lausanne Hospitals
Responsible party: John O. Prior (Chief of the Department of Nuclear medicine, University of Lausanne Hospitals) — Principal investigator
First posted: Nov 22, 2016
Start date: Apr 2013
Primary completion: Dec 31, 2018
Completion: Dec 31, 2018
Last update: Mar 23, 2020

Study contacts

John O Prior, MD PhD

principal investigator · Lausanne University Hospitals

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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