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

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ClinicalTrials.gov Identifier: NCT02799979
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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.


Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Device: 3D right ventricular imaging echocardiographic

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : June 2019


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.




Primary Outcome Measures :
  1. Number of death from any cause [ Time Frame: Baseline to 24 months ]
    Description of the number of death during the study


Secondary Outcome Measures :
  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 (%)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary hypertension diagnosed
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799979


Contacts
Contact: PAMELA MOCERI, MD 4 92 03 77 34 ext +33 moceri.p@chu-nice.fr

Locations
France
Hopital Pasteur - Chu Nice Recruiting
Nice, France, 06000
Contact: PAMELA MOCERI, MD    4 92 03 77 34 ext +33    moceri.p@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: PAMELA MOCERI, MD CHU NICE

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02799979     History of Changes
Other Study ID Numbers: 14-AOI-08
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases