3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

NCT02799979 | Unknown

• 1 other identifier: 14-AOI-08
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of death from any cause

  Description of the number of death during the study

  Baseline to 24 months

Secondary Outcomes (2)

• Number of Hospitalisation

  Baseline to 24 months

• 3D right ventricular imaging echocardiographic

  Baseline and 6 months

Study Arms (2)

Case

Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months

Device: 3D right ventricular imaging echocardiographic

Control

Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline

Device: 3D right ventricular imaging echocardiographic

Interventions

3D right ventricular imaging echocardiographic DEVICE

Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary hypertension diagnosed

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Hopital Pasteur - Chu Nice

Nice, 06000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36265185 DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• PAMELA MOCERI, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PAMELA MOCERI, MD

CONTACT

4 92 03 77 34; moceri.p@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 15, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)