Myocardial DysfunctionNCT02970851
Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH
An observational study of Myocardial Dysfunction and Endothelial Dysfunction, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Dysfunction, Endothelial Dysfunction
- How many people
- 2 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for Bosentan therapy
Who may be able to join
- 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
Who cannot join
- 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%
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
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
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
- 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
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline
On the images 82Rb PET/CT rest MBF
myocardial blood flow (MBF in mL/min/g) at rest
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
On the images 82Rb PET/CT stress MBF
myocardial blood flow (MBF in mL/min/g) at pharmacological stress
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 12 weeks after start of treatment
Secondary outcomes (14)
Analysis of right heart catheterization parameters PAP
pulmonary arterial pressure (PAP)
Measured: at screening
Analysis of right heart catheterization parameters PAP
PAP
Measured: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters RAP
right atrial pressure (RAP)
Measured: at screening
Analysis of right heart catheterization parameters RAP
RAP
Measured: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters PWP
pulmonary wedge pressure (PWP)
Measured: at screening
Analysis of right heart catheterization parameters PWP
PWP
Measured: at 12 weeks after start of treatment
Analysis of clinical parameters NYHA
NYHA classification
Measured: at screening
Analysis of clinical parameters NYHA
New York Heart Association (NYHA) classification
Measured: at 12 weeks after start of treatment
Analysis of clinical parameters 6-min walk test
6-minute walk test
Measured: at screening
Analysis of clinical parameters 6-min walk test
6-minute walk test
Measured: at 12 weeks after start of treatment
Analysis of clinical parameters LFT
Results of lung function tests
Measured: at screening
Analysis of clinical parameters LFT
Results of lung function tests
Measured: at 12 weeks after start of treatment
Analysis of clinical parameters NT-pro-BNP
plasmatic N terminal - pro - Brain Natriuretic Peptide (NT-pro-BNP)
Measured: at screening
Analysis of clinical parameters NT-pro-BNP
plasmatic NT-pro-BNP
Measured: at 12 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startApr 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: Slow patient recruitment after arrival of macitentan on the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O Prior, MD PhD, Principal investigator, Lausanne University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970851
- Sponsor's protocol ID
- 08/12
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2016
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02970851
- Acronym / sponsor ID
- 08/12
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow patient recruitment after arrival of macitentan on the market
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for Bosentan therapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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)
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)
On the images 82Rb PET/CT rest MBF
Time frame: Baseline
myocardial blood flow (MBF in mL/min/g) at rest
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
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
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
On the images 82Rb PET/CT stress MBF
Time frame: Baseline
myocardial blood flow (MBF in mL/min/g) at pharmacological stress
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
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
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
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
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
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
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
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)
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)
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)
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)
14 secondary outcomes
Analysis of right heart catheterization parameters PAP
Time frame: at screening
Analysis of right heart catheterization parameters PAP
Time frame: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters RAP
Time frame: at screening
Analysis of right heart catheterization parameters RAP
Time frame: at 12 weeks after start of treatment
Analysis of right heart catheterization parameters PWP
Time frame: at screening
Analysis of right heart catheterization parameters PWP
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters NYHA
Time frame: at screening
Analysis of clinical parameters NYHA
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters 6-min walk test
Time frame: at screening
Analysis of clinical parameters 6-min walk test
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters LFT
Time frame: at screening
Analysis of clinical parameters LFT
Time frame: at 12 weeks after start of treatment
Analysis of clinical parameters NT-pro-BNP
Time frame: at screening
Analysis of clinical parameters NT-pro-BNP
Time frame: at 12 weeks after start of treatment
Results and safety
The study was stopped early (reason given: Slow patient recruitment after arrival of macitentan on the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Myocardial Dysfunction
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Not yet recruitingObservational study
PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study
Heart Failure, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John O Prior, MD PhD principal investigator
Lausanne University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Dysfunction and Endothelial Dysfunction, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow patient recruitment after arrival of macitentan on the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of each method of imaging for assessment of myocardial metabolism (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.