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Clinical Trials/NCT02799979
NCT02799979
Unknown
Not Applicable

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Centre Hospitalier Universitaire de Nice1 site in 1 country150 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Arterial Hypertension
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
150
Locations
1
Primary Endpoint
Number of death from any cause
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
June 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of death from any cause

Time Frame: Baseline to 24 months

Description of the number of death during the study

Secondary Outcomes

  • Number of Hospitalisation(Baseline to 24 months)
  • 3D right ventricular imaging echocardiographic(Baseline and 6 months)

Study Sites (1)

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