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OpenTrials
Completed

NCT Number: NCT02799979

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

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.

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Pasteur - Chu Nice

Nice, 06000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D right ventricular imaging echocardiographic

Device

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

Primary outcomes

  1. Number of death from any cause

    Time frame: Baseline to 24 months

    Description of the number of death during the study

Secondary outcomes

  1. Number of Hospitalisation

    Time frame: Baseline to 24 months

    Description of the number of hospitalisation for worsening of pulmonary arterial hypertension

  2. 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 (%)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: HTP3S

Important dates

Study start
2014
Primary completion
2021
Study completion
2022
First posted
Jun 15, 2016
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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