Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionPRINCEPTNCT03205085
Determinants of Right Heart Remodeling in Patients With CTEPH or PAH
A study testing magnetic resonance imaging, 2D and 3D trans-thoracic echocardiography and Blood samples in people with Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Right heart failure is the main cause of morbi-mortality in patients with pulmonary hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension
- What is being tested?
- magnetic resonance imaging, 2D and 3D trans-thoracic echocardiography and Blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2017to 1 Jul 2020
- 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
- adults (age > 18 years old)
- who give their informed consent for the protocol
- with either CTEPH referred to our insitution for pulmonary arterial endarterectomy. CTEPH is defined by invasive mean pulmonary arterial pressure ≥ 25mmHg at rest, secondary to chronic pulmonary embolism confirmed by computed tomographic (CT) angiography and/or ventilation/perfusion scan, according to the lastest guidelines
- Or with PAH referred to our institution for lung transplant. PAH is defined according to the latest guidelines by an invasive mean pulmonary arterial pressure ≥ 25mmHg, secondary to idiopathic, familial, drug or toxin, or connective tissue disease etiology.
Who cannot join
- pregnant women
- children
- congenital heart diseases
- contraindications for MRI such as metallic foreign bodies or devices, claustrophobia
- contraindication for surgery
- patients requiring preoperative mechanical assistance such as extracorporeal membrane oxygenation
- patients with pulmonary arterial sarcoma
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Marie Lannelongue
Le Plessis-Robinson, 92350
About this study
Official title: Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation
Right heart failure is the main cause of morbi-mortality in patients with pulmonary hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Endarterectomy is an effective treatment for patients with CTEPH to lower pulmonary pressure. Evidence of postoperative right heart remodeling are contrasted according to the studies and determinants of right heart failure are still unclear. Similarly, few evidence exists on right ventricular remodeling after bilateral lung transplantation for patients with pulmonary arterial hypertension (PAH). Recent evidence have supported the role of inflammation and immunity in the pathophysiology of PAH . While several cytokines have been shown to predict survival , little is known on the implication of inflammation and immunity in postoperative Right Ventricular failure in patients with PAH.
- The specific translational goal of this current project is to elucidate the role of immune biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or PAH. We speculate that selected immune biomarkers (such as CXCL9, interleukin -18 or interferon) and growth factors (such as HGF) are correlated with mid-term postoperative right heart failure.
All consecutive adults with either CTEPH referred to our center for endarterectomy, or PAH referred for lung transplantation, will be included, aiming for 150 CTEPH and 50 PAH. After inclusion, patients will undergo assessment of right heart dimensions and function by cardiac magnetic resonance imaging (MRI, including 4-Dimensions blood flow sequences) and 2D and 3D trans-thoracic echocardiography (TTE), as well as immune panel analysis. All patients will undergo as part of routine care right heart catheterization within a week after TTE and MRI imaging. On the day of surgery, pulmonary pressure will be measured by right heart catheterization monitoring (as part of routine care) in order to estimate the drop of pressure and to adjust for the extent of endarterectomy for patients with CTEPH. TTE will also be performed on the day of surgery if possible. At 7 days post-endarterectomy or transplant, clinical outcomes will be collected and peripheral blood will be collected. Patients will be prospectively follow-up for 6 months. Death, need for reintervention, duration of vasopressor after surgery and number, duration and cause of readmission will be recorded. At 6 months after surgery, all survivors will undergo the same biological sampling, as well as an 4D MRI and a 2D and 3D TTE. Data of right heart catheterization at 6 months (as part of routine care) will be collected as well.
- Being tested
- magnetic resonance imaging, 2D and 3D trans-thoracic echocardiography, Blood samples
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingRadiation
assessment of right heart dimensions and function by cardiac magnetic resonance Imaging.
2D and 3D trans-thoracic echocardiographyProcedure or surgery
assessment of right heart dimensions and function by 2D and 3D trans-thoracic echocardiography
Blood samplesOther
Blood samples for assays of immune inflammatory biomarkers (InterLeukin-18, CXCL9 or interferon
| Study group | Role | What they receive |
|---|---|---|
| CTEPH PATIENTS | Experimental | Patients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). Receives: Radiation: magnetic resonance imaging; Procedure: 2D and 3D trans-thoracic echocardiography; Other: Blood samples |
| PAH PATIENTS | Experimental | patients with pulmonary arterial hypertension (PAH) undergoing lung transplantation Receives: Radiation: magnetic resonance imaging; Procedure: 2D and 3D trans-thoracic echocardiography; Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
right ventricular adverse remodeling
postoperative right ventricular adverse remodeling, defined by increase above 10% in end-systolic right ventricular volume indexed on body surface area assessed by cardiac MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start9 Aug 2017
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205085
- Sponsor's protocol ID
- 2017-A00785-48
- Acronym
- PRINCEPT
- Status last verified
- Jan 2020
- First submitted
- 28 Jun 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
Publications
Azarine A, Kasani K, Kim YW, Sakhi H, Amsallem M, Aubrege L, Chevance V, Hauguel A, Humbert M, Savale L, Jais X, Montani D, Marsden A, Fadel E, Le Pavec J, Mercier O, Haddad F. The Importance of Postprocessing Methods for Assessing Right Ventricular Volumes and Function in Patients With Pulmonary Hypertension: Results From the Postoperative Right Heart Remodeling in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation Study. Chest. 2026 May 14:S0012-3692(26)00557-X. doi: 10.1016/j.chest.2026.04.017. Online ahead of print.
PubMed 42134497Dong ML, Azarine A, Haddad F, Amsallem M, Kim YW, Yang W, Fadel E, Aubrege L, Loecher M, Ennis D, Pavec JL, Vignon-Clementel I, Feinstein JA, Mercier O, Marsden AL. 4D flow cardiovascular magnetic resonance recovery profiles following pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension. J Cardiovasc Magn Reson. 2022 Nov 14;24(1):59. doi: 10.1186/s12968-022-00893-x.
PubMed 36372884
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
- Determinants of Postoperative Right Heart Remodeling in Patients With Chronic Thrombo-Embolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation
- ClinicalTrials.gov ID
- NCT03205085
- Acronym / sponsor ID
- PRINCEPT / 2017-A00785-48
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 2 Jul 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.
Right heart failure is the main cause of morbi-mortality in patients with pulmonary hypertension (PH), including patients of chronic thrombo-embolic pulmonary hypertension (CTEPH) or pulmonary arterial hypertension (PAH) etiologies. Endarterectomy is an effective treatment for patients with CTEPH to lower pulmonary pressure. Evidence of postoperative right heart remodeling are contrasted according to the studies and determinants of right heart failure are still unclear. Similarly, few evidence exists on right ventricular remodeling after bilateral lung transplantation for patients with pulmonary arterial hypertension (PAH). Recent evidence have supported the role of inflammation and immunity in the pathophysiology of PAH . While several cytokines have been shown to predict survival , little is known on the implication of inflammation and immunity in postoperative Right Ventricular failure in patients with PAH.
- The specific translational goal of this current project is to elucidate the role of immune biomarkers in 6 months postoperative right heart adverse remodeling in patients with CTEPH or PAH. We speculate that selected immune biomarkers (such as CXCL9, interleukin -18 or interferon) and growth factors (such as HGF) are correlated with mid-term postoperative right heart failure.
All consecutive adults with either CTEPH referred to our center for endarterectomy, or PAH referred for lung transplantation, will be included, aiming for 150 CTEPH and 50 PAH. After inclusion, patients will undergo assessment of right heart dimensions and function by cardiac magnetic resonance imaging (MRI, including 4-Dimensions blood flow sequences) and 2D and 3D trans-thoracic echocardiography (TTE), as well as immune panel analysis. All patients will undergo as part of routine care right heart catheterization within a week after TTE and MRI imaging. On the day of surgery, pulmonary pressure will be measured by right heart catheterization monitoring (as part of routine care) in order to estimate the drop of pressure and to adjust for the extent of endarterectomy for patients with CTEPH. TTE will also be performed on the day of surgery if possible. At 7 days post-endarterectomy or transplant, clinical outcomes will be collected and peripheral blood will be collected. Patients will be prospectively follow-up for 6 months. Death, need for reintervention, duration of vasopressor after surgery and number, duration and cause of readmission will be recorded. At 6 months after surgery, all survivors will undergo the same biological sampling, as well as an 4D MRI and a 2D and 3D TTE. Data of right heart catheterization at 6 months (as part of routine care) will be collected as well.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTEPH PATIENTS | Experimental | Radiation: magnetic resonance imaging, Procedure: 2D and 3D trans-thoracic echocardiography, Other: Blood samplesPatients undergoing pulmonary endarterectomy for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). |
| PAH PATIENTS | Experimental | Radiation: magnetic resonance imaging, Procedure: 2D and 3D trans-thoracic echocardiography, Other: Blood samplespatients with pulmonary arterial hypertension (PAH) undergoing lung transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (age > 18 years old)
- who give their informed consent for the protocol
- with either CTEPH referred to our insitution for pulmonary arterial endarterectomy. CTEPH is defined by invasive mean pulmonary arterial pressure ≥ 25mmHg at rest, secondary to chronic pulmonary embolism confirmed by computed tomographic (CT) angiography and/or ventilation/perfusion scan, according to the lastest guidelines
- Or with PAH referred to our institution for lung transplant. PAH is defined according to the latest guidelines by an invasive mean pulmonary arterial pressure ≥ 25mmHg, secondary to idiopathic, familial, drug or toxin, or connective tissue disease etiology.
Key exclusion criteria (7 listed)
- pregnant women
- children
- congenital heart diseases
- contraindications for MRI such as metallic foreign bodies or devices, claustrophobia
- contraindication for surgery
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 |
|---|---|---|
| magnetic resonance imagingassessment of right heart dimensions and function by cardiac magnetic resonance Imaging. | Radiation | CTEPH PATIENTS, PAH PATIENTS |
| 2D and 3D trans-thoracic echocardiographyassessment of right heart dimensions and function by 2D and 3D trans-thoracic echocardiography | Procedure or surgery | CTEPH PATIENTS, PAH PATIENTS |
| Blood samplesBlood samples for assays of immune inflammatory biomarkers (InterLeukin-18, CXCL9 or interferon | Other | CTEPH PATIENTS, PAH PATIENTS |
Primary outcome
right ventricular adverse remodeling
Time frame: 6 months
postoperative right ventricular adverse remodeling, defined by increase above 10% in end-systolic right ventricular volume indexed on body surface area assessed by cardiac MRI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 42134497Azarine A, Kasani K, Kim YW, Sakhi H, Amsallem M, Aubrege L, Chevance V, Hauguel A, Humbert M, Savale L, Jais X, Montani D, Marsden A, Fadel E, Le Pavec J, Mercier O, Haddad F. The Importance of Postprocessing Methods for Assessing Right Ventricular Volumes and Function in Patients With Pulmonary Hypertension: Results From the Postoperative Right Heart Remodeling in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy, or Pulmonary Arterial Hypertension After Lung Transplantation Study. Chest. 2026 May 14:S0012-3692(26)00557-X. doi: 10.1016/j.chest.2026.04.017. Online ahead of print.
- Derived from this study: PubMed 36372884Dong ML, Azarine A, Haddad F, Amsallem M, Kim YW, Yang W, Fadel E, Aubrege L, Loecher M, Ennis D, Pavec JL, Vignon-Clementel I, Feinstein JA, Mercier O, Marsden AL. 4D flow cardiovascular magnetic resonance recovery profiles following pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension. J Cardiovasc Magn Reson. 2022 Nov 14;24(1):59. doi: 10.1186/s12968-022-00893-x.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging, 2D and 3D trans-thoracic echocardiography and Blood samples in people with Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial 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 4 inclusion and 7 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LILIA LAMRANI (01.40.94.25.54 ext. 33, l.lamrani@ccml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular adverse remodeling (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03205085, which also lists 2 linked publications.
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.