Chronic Thromboembolic Pulmonary HypertensionMVDNCT03199131
The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging
A study testing Right ventricular biopsies in people with Chronic Thromboembolic Pulmonary Hypertension, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. 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?
- Right ventricular biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2017to 20 Oct 2018
- Phase
- Interventional
- 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
None listed.
Who cannot join
- Chronic thromboembolic pulmonary hypertension group:
- Insufficient biopsy material,
- pre-operative therapy with bosentan or sildenafil
- Control group:
- Insufficient biopsy sample,
- ischemic cardiomyopathy,
- miral or tricuspid valve disease,
- pre-operative pulmonary hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.
Read the detailed description
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage. As right heart failure is the primary outcome determinant in patients with pulmonary hypertension, understanding the major mediators of RV compensation, failure and recovery is essential to improving patient survival. Recently, there have been significant advances in the ability to assess RV function in vivo using functional imaging techniques, including positron emission tomography (PET) and cardiac MRI (CMR). CMR is an established and validated method of precisely defining cardiac structure and function, and new PET protocols have been developed that measure glucose utilization, oxygen consumption, apoptosis and angiogenesis. Importantly, the in vivo nature of PET and CMR allow for the non-invasive collection of detailed structural, metabolic and physiologic data on the performance of the RV5. When taken in combination with established echocardiographic evaluation, these new platforms allow in-depth analysis of cardiac structure and function without the need for invasive procedures. In order to maximize the potential of these techniques, however, a molecular imaging target needs to be identified so as to allow physicians to detect the transition from a compensated to decompensated state. Such a marker has not yet been reported
- Being tested
- Right ventricular biopsies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ventricular biopsiesProcedure or surgery
a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).
| Study group | Role | What they receive |
|---|---|---|
| CTEPH | Experimental | Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). Receives: Procedure: Right ventricular biopsies |
| Control group | Other | Patients undergoing adult cardiac surgery without evidence of pulmonary hypertension. Receives: Procedure: Right ventricular biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between the metabolic, morphologic and functional alterations in the right ventricle
Measured: to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery.
Secondary outcomes (1)
validation in human subjects of metabolic signaling pathway alterations found in animal model
Measured: analyse gene and protein expression during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start20 Feb 2017
- Primary completion20 Nov 2017
- Study completion20 Oct 2018
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olaf Mercier, MD, PhD, Principal investigator, Marie Lannelongue Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199131
- Sponsor's protocol ID
- 2015-A00149-40
- Acronym
- MVD
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2017
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging
- ClinicalTrials.gov ID
- NCT03199131
- Acronym / sponsor ID
- MVD / 2015-A00149-40
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Oct 2018 (actual)
- First posted
- 26 Jun 2017 (actual)
- 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.
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.
Detailed description
Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage. As right heart failure is the primary outcome determinant in patients with pulmonary hypertension, understanding the major mediators of RV compensation, failure and recovery is essential to improving patient survival. Recently, there have been significant advances in the ability to assess RV function in vivo using functional imaging techniques, including positron emission tomography (PET) and cardiac MRI (CMR). CMR is an established and validated method of precisely defining cardiac structure and function, and new PET protocols have been developed that measure glucose utilization, oxygen consumption, apoptosis and angiogenesis. Importantly, the in vivo nature of PET and CMR allow for the non-invasive collection of detailed structural, metabolic and physiologic data on the performance of the RV5. When taken in combination with established echocardiographic evaluation, these new platforms allow in-depth analysis of cardiac structure and function without the need for invasive procedures. In order to maximize the potential of these techniques, however, a molecular imaging target needs to be identified so as to allow physicians to detect the transition from a compensated to decompensated state. Such a marker has not yet been reported
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTEPH | Experimental | Procedure: Right ventricular biopsiesPatients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). |
| Control group | Other | Procedure: Right ventricular biopsiesPatients undergoing adult cardiac surgery without evidence of pulmonary hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Insufficient biopsy material,
- pre-operative therapy with bosentan or sildenafil
- Insufficient biopsy sample,
- ischemic cardiomyopathy,
- miral or tricuspid valve disease,
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 |
|---|---|---|
| Right ventricular biopsiesa right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group). | Procedure or surgery | CTEPH, Control group |
Primary outcome
relationship between the metabolic, morphologic and functional alterations in the right ventricle
Time frame: to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery.
1 secondary outcome
validation in human subjects of metabolic signaling pathway alterations found in animal model
Time frame: analyse gene and protein expression during surgery
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 23 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Chronic Thromboembolic Pulmonary Hypertension
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
Olaf Mercier, MD, PhD principal investigator
Marie Lannelongue Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right ventricular biopsies in people with Chronic Thromboembolic Pulmonary Hypertension, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 0 inclusion and 8 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 23 Jan 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 France. 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 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?
relationship between the metabolic, morphologic and functional alterations in the right ventricle (time frame: to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery.). 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 Jan 2020.