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NCT02799979 Clinical Trial

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— HTP3S  

Official title:
3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02799979
Other study ID # 14-AOI-08
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2016
Last updated October 3, 2017
Start date October 2014
Est. completion date June 2019

Study information
Verified date October 2017
Source Centre Hospitalier Universitaire de Nice
Contact PAMELA MOCERI, MD
Phone 4 92 03 77 34
Email moceri.p@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2019
Est. primary completion date October 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Pasteur - Chu Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of death from any cause Description of the number of death during the study Baseline to 24 months
Secondary Number of Hospitalisation Description of the number of hospitalisation for worsening of pulmonary arterial hypertension Baseline to 24 months
Secondary 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
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