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

June 15, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Hopital Pasteur - Chu Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline to 24 months
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
Time Frame: Baseline to 24 months
Description of the number of hospitalisation for worsening of pulmonary arterial hypertension
Baseline to 24 months
3D right ventricular imaging echocardiographic
Time Frame: Baseline and 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2014

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

February 2, 2022

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimated)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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