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3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

NCT ID: NCT02799979

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

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

3D right ventricular imaging echocardiographic

Intervention Type DEVICE

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

3D right ventricular imaging echocardiographic

Intervention Type DEVICE

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

Interventions

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3D right ventricular imaging echocardiographic

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PAMELA MOCERI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Locations

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Hopital Pasteur - Chu Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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PAMELA MOCERI, MD

Role: CONTACT

[email protected]
4 92 03 77 34 ext. +33

Facility Contacts

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PAMELA MOCERI, MD

Role: primary

[email protected]
4 92 03 77 34 ext. +33

References

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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.

Reference Type DERIVED
PMID: 36265185 (View on PubMed)

Other Identifiers

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14-AOI-08

Identifier Type: -

Identifier Source: org_study_id