NCT03205085: PRINCEPT

Determinants of Right Heart Remodeling in Patients With CTEPH or PAH

Status unknown NA Last updated 23 January 2020

What this trial tests

NA trial testing magnetic resonance imaging in Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension in 150 participants. Status unknown.

Timeline

9 August 2017

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Centre Chirurgical Marie Lannelongue
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	150
Start date	9 August 2017
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across France

Drugs / interventions tested

• magnetic resonance imaging
• 2D and 3D trans-thoracic echocardiography
• Blood samples — full drug profile →

Conditions studied

• Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension — all drugs for Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension →

Sponsor

Centre Chirurgical Marie Lannelongue — full company profile →

Who can join

18 and older, any sex, with Chronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 4D flow cardiovascular magnetic resonance recovery profiles following pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension.
   Dong ML, Azarine A, Haddad F, Amsallem M, et al · · 2022 · cited 6× · PMID 36372884 · DOI 10.1186/s12968-022-00893-x
2. 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 Pul
   Azarine A, Kasani K, Kim YW, Sakhi H, et al · · 2026 · PMID 42134497 · DOI 10.1016/j.chest.2026.04.017