3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Device: 3D right ventricular imaging echocardiographic

• Registration Number: NCT02799979
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound.

The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension.

To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-05
• Primary Completion: 2018-10
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients > 18 years old
• Pulmonary hypertension diagnosed by right heart catheterization
• Informed consent obtained
• Affiliation to the French national health insurance

Exclusion Criteria

• Associated significant left heart disease
• Sub-optimal acoustic windows
• Patient unable to attend follow-up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	3D right ventricular imaging echocardiographic	Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months
Control	3D right ventricular imaging echocardiographic	Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline

Primary Outcome Measures

Name	Time	Method
Number of death from any cause	Baseline to 24 months	Description of the number of death during the study

Secondary Outcome Measures

Name	Time	Method
Number of Hospitalisation	Baseline to 24 months	Description of the number of hospitalisation for worsening of pulmonary arterial hypertension
3D right ventricular imaging echocardiographic	Baseline and 6 months	Analyse the data of 3D right ventricular (RV), ejection fraction, RV telediastolic and telesystolic volume, 3D RV area strain (%)

Trial Locations

Locations (1)

Hopital Pasteur - Chu Nice; 🇫🇷 Nice, France