3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension (HTP3S)

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Device: 3D right ventricular imaging echocardiographic

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: PAMELA MOCERI, MD; Phone Number: +33 4 92 03 77 34; Email: moceri.p@chu-nice.fr

Study Locations

• France
  • Nice, France, 06000
    • Recruiting
    • Hôpital Pasteur - CHU Nice
    • Contact: PAMELA MOCERI, MD; Phone Number: +33 4 92 03 77 34; Email: moceri.p@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary hypertension diagnosed

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months	Device: 3D right ventricular imaging echocardiographic; Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.
Control; Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline	Device: 3D right ventricular imaging echocardiographic; Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of death from any cause	Description of the number of death during the study	Baseline to 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: PAMELA MOCERI, MD, CHU Nice

Publications and helpful links

General Publications

• Moceri P, Duchateau N, Baudouy D, Squara F, Bun SS, Ferrari E, Sermesant M. Additional prognostic value of echocardiographic follow-up in pulmonary hypertension-role of 3D right ventricular area strain. Eur Heart J Cardiovasc Imaging. 2022 Oct 20;23(11):1562-1572. doi: 10.1093/ehjci/jeab240.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 14-AOI-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No