Chronic Thromboembolic Pulmonary HypertensionPhase 2NCT02094001
Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH
A Phase 2 study testing Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3) in people with Chronic Thromboembolic Pulmonary Hypertension, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive pulmonary hypertension (PH) and right ventricular failure- most common cause of death for patients with PH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jun 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be able to provide their written informed consent to participate in the study after having received adequate previous information and prior to any study specific procedures.
- At least 18 years of age at the time of screening.
- Receiving riociguat therapy for CTEPH.
- Patients with inoperable CTEPH or persistent or recurrent PH, after undergoing pulmonary endarterectomy.
- CTEPH diagnosis will be based on either Ventilation/ Perfusion scan (V/Q), pulmonary angiography or computed tomography pulmonary angiography..
- Clinical right heart catheterization performed confirming mean pulmonary artery pressure (mPAP >25 mmHg).
- Pulmonary vascular resistance (PVR) > 300 dyne/sec/cm5
Who cannot join
- • All types of pulmonary hypertension except Dana Point Classification Group 4 (1).
- Patients who are currently taking Phosphodiesterase type 5 (PDE-5) inhibitors, ERAs and prostanoids ≤ 3 days prior to start of riociguat treatment.
- Pulmonary endarterectomy surgery within 3 months of screening.
- Epicardial coronary artery disease (Ejection Fraction <40%).
- Previous myocardial infarction within the 3 months prior to screening.
- Severe proven or suspected coronary artery disease (CCS Angina Classification II-IV), and/or requiring nitrates.
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- Uncontrolled arterial hypertension (systolic blood pressure> 180 mmHg and/or diastolic BP> 110 mmHg.
- Systolic blood pressure <95mmHg.
- Resting heart rate in an awake patient <50 beats per minute (bpm) or >105 bpm.
- History of uncontrolled atrial fibrillation within the last 3 months prior to screening.
- Hypertrophic obstructive cardiomyopathy.
- Clinical evidence of symptomatic atherosclerotic disease (peripheral artery disease).
- Pregnant or breastfeeding women or women with childbearing potential not using highly effective contraception methods.
- Renal insufficiency (glomerular filtration rate < 30 ml/min.
- ALT or AST > times upper limit of normal( ULN) and/or severe hepatic insufficiency.
- Contraindication to MRI imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of Rio
Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive pulmonary hypertension (PH) and right ventricular failure- most common cause of death for patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved in Canada for the treatment of CTEPH.
This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will show changes in glucose metabolism and improved resting myocardial blood flow using positron emission tomography ( PET ) imaging to measure myocardial function. The response between both treatment naive patients as well as patients on maximally tolerated dose of riociguat with tratment duration of at least 3 months will be included.
Read the detailed description
It remains unclear as to why certain patients with PH develop right heart failure. Several lines of evidence suggests alterations in right ventricular (RV) function may be precipitated by RV ischemia. This ischemia results from both decreased right coronary artery perfusion pressure and from arteriolar- capillary rarefaction. It has been proposed that this contributes to insufficient oxygen delivery needed to support the increase RV demand in right heart failure (RHF), this stimulating glycolytic shift. However, this glycolysis is insufficient to compensate for suppression of glucose oxidation in severe right ventricular hypertrophy (RVH), resulting in a state of RV hibernation and progressive RHF.
This study is designed to assess if 24 weeks of treatment with riociguat will be associated with changes in glucose metabolism and improved RV blood flow using N-13-ammonia (NH3) to measure myocardial perfusion.
We will assess the response in both treatment naive patients as well as patients who have been titrated to maximally tolerated doses of riociguat with total treatment duration of at least 3 months.
The assessment of quantitative myocardial blood flow will be combined with an advanced 3 dimensional echocardiographic assessment of RV volume and function and with cardiac magnetic resonance (MR).
- Being tested
- Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)Radiation
After an overnight fast, patients will undergo a 20 minute dynamic PET scan with injection of 3 MBq/kg of N-13 ammonia (NH3) to measure myocardial perfusion. Followed by a 60 min dynamic PET scan with injection of 3MBq/kg of F-18-FDG to measure glucose uptake.
| Study group | Role | What they receive |
|---|---|---|
| Riociguat therapy | Experimental | After an overnight fast, patients will undergo a 20 minute dynamic PET scan with injection of 3 MBq/kg of N-13 ammonia (NH3) to measure myocardial perfusion. Followed by a 60 min dynamic PET scan with injection of 3MBq/kg of F-18-FDG to measure glucose uptake. Receives: Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of changes in glucose metabolism and myocardial RV blood flow in patients treated with riociguat using PET imaging.
Subjects will undergo FDG (fluorodeoxyglucose, F-18)cardiac positron emission tomography studies (PET) at baseline and 24 weeks to assess regional myocardial blood flow. The assessment of regional myocardial blood flow will be combined with 3D echocardiography and magnetic resonance (MR)
Measured: After 24 weeks of treatment with riociguat.
Secondary outcomes (1)
Evidence of improved RV function and volumes using 3D echocardiography and magnetic resonance imagining (MRI)
The assessment of will be obtained by 3D echocardiography and MRI to evaluate RV function.
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Lisa Mielniczuk, Ottawa Heart Institute Research Corporation
- Investigators
- Lisa M Mielniczuk, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094001
- Sponsor's protocol ID
- 20130903-01H
- Status last verified
- Jun 2017
- First submitted
- 17 Mar 2014
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of Rio
- ClinicalTrials.gov ID
- NCT02094001
- Acronym / sponsor ID
- 20130903-01H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Mar 2014 (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.
Chronic thromboembolic Pulmonary hypertension(CTEPH) is characterized by obstruction of the pulmonary vasculature, leading to increased pulmonary vascular resistance, progressive pulmonary hypertension (PH) and right ventricular failure- most common cause of death for patients with PH. Riociguat, (ADEMPAS) is a member of a new class of drug recently approved in Canada for the treatment of CTEPH.
This pilot study is designed to assess if at least 24 weeks of treatment with riociguat will show changes in glucose metabolism and improved resting myocardial blood flow using positron emission tomography ( PET ) imaging to measure myocardial function. The response between both treatment naive patients as well as patients on maximally tolerated dose of riociguat with tratment duration of at least 3 months will be included.
Detailed description
It remains unclear as to why certain patients with PH develop right heart failure. Several lines of evidence suggests alterations in right ventricular (RV) function may be precipitated by RV ischemia. This ischemia results from both decreased right coronary artery perfusion pressure and from arteriolar- capillary rarefaction. It has been proposed that this contributes to insufficient oxygen delivery needed to support the increase RV demand in right heart failure (RHF), this stimulating glycolytic shift. However, this glycolysis is insufficient to compensate for suppression of glucose oxidation in severe right ventricular hypertrophy (RVH), resulting in a state of RV hibernation and progressive RHF.
This study is designed to assess if 24 weeks of treatment with riociguat will be associated with changes in glucose metabolism and improved RV blood flow using N-13-ammonia (NH3) to measure myocardial perfusion.
We will assess the response in both treatment naive patients as well as patients who have been titrated to maximally tolerated doses of riociguat with total treatment duration of at least 3 months.
The assessment of quantitative myocardial blood flow will be combined with an advanced 3 dimensional echocardiographic assessment of RV volume and function and with cardiac magnetic resonance (MR).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Riociguat therapy | Experimental | Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)After an overnight fast, patients will undergo a 20 minute dynamic PET scan with injection of 3 MBq/kg of N-13 ammonia (NH3) to measure myocardial perfusion. Followed by a 60 min dynamic PET scan with injection of 3MBq/kg of F-18-FDG to measure glucose uptake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be able to provide their written informed consent to participate in the study after having received adequate previous information and prior to any study specific procedures.
- At least 18 years of age at the time of screening.
- Receiving riociguat therapy for CTEPH.
- Patients with inoperable CTEPH or persistent or recurrent PH, after undergoing pulmonary endarterectomy.
- CTEPH diagnosis will be based on either Ventilation/ Perfusion scan (V/Q), pulmonary angiography or computed tomography pulmonary angiography..
Key exclusion criteria (16 listed)
- • All types of pulmonary hypertension except Dana Point Classification Group 4 (1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)After an overnight fast, patients will undergo a 20 minute dynamic PET scan with injection of 3 MBq/kg of N-13 ammonia (NH3) to measure myocardial perfusion. Followed by a 60 min dynamic PET scan with injection of 3MBq/kg of F-18-FDG to measure glucose uptake. | Radiation | Riociguat therapy |
Primary outcome
Evidence of changes in glucose metabolism and myocardial RV blood flow in patients treated with riociguat using PET imaging.
Time frame: After 24 weeks of treatment with riociguat.
Subjects will undergo FDG (fluorodeoxyglucose, F-18)cardiac positron emission tomography studies (PET) at baseline and 24 weeks to assess regional myocardial blood flow. The assessment of regional myocardial blood flow will be combined with 3D echocardiography and magnetic resonance (MR)
1 secondary outcome
Evidence of improved RV function and volumes using 3D echocardiography and magnetic resonance imagining (MRI)
Time frame: baseline and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Lisa M Mielniczuk, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3) in people with Chronic Thromboembolic Pulmonary Hypertension, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 29 Aug 2018. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evidence of changes in glucose metabolism and myocardial RV blood flow in patients treated with riociguat using PET imaging. (time frame: After 24 weeks of treatment with riociguat.). 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 29 Aug 2018.