## Protocol Section
### Identification Module
**NCT ID:** NCT02799979

**Acronym:** HTP3S

**Brief Title:** 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

**Official Title:** 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

#### Organization Study ID Info
**ID:** 14-AOI-08
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Nice
### Status Module
#### Completion Date
**Date:** 2019-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-10-05

**Type:** ACTUAL

**Last Update Submit Date:** 2017-10-03

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2018-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2014-10

**Status Verified Date:** 2017-10

#### Study First Post Date
**Date:** 2016-06-15
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-30
**Study First Submit QC Date:** 2016-06-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Nice

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pulmonary Arterial Hypertension

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 150

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: 3D right ventricular imaging echocardiographic

**Label:** Case

#### Arm Group 2

**Description:** Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline

**Intervention Names:**

- Device: 3D right ventricular imaging echocardiographic

**Label:** Control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Case

- Control

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

**Name:** 3D right ventricular imaging echocardiographic

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Description of the number of death during the study

**Measure:** Number of death from any cause

**Time Frame:** Baseline to 24 months

#### Secondary Outcomes

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

**Measure:** Number of Hospitalisation

**Time Frame:** Baseline to 24 months

**Description:** Analyse the data of 3D right ventricular (RV), ejection fraction, RV telediastolic and telesystolic volume, 3D RV area strain (%)

**Measure:** 3D right ventricular imaging echocardiographic

**Time Frame:** Baseline and 6 months

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with pulmonary hypertension diagnosed

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** moceri.p@chu-nice.fr

**Name:** PAMELA MOCERI, MD

**Phone:** 4 92 03 77 34

**Phone Ext:** +33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Nice

**Contacts:**

***Contact 1:***

- **Email:** moceri.p@chu-nice.fr

- **Name:** PAMELA MOCERI, MD

- **Phone:** 4 92 03 77 34

- **Phone Ext:** +33

- **Role:** CONTACT

**Country:** France

**Facility:** Hopital Pasteur - Chu Nice

**Status:** RECRUITING

**Zip:** 06000

#### Overall Officials

**Official 1:**

**Affiliation:** CHU NICE

**Name:** PAMELA MOCERI, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** YES

### References Module

#### References

**Citation:** 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.

**PMID:** 36265185

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M2261

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: LOW

- As Found: Unknown

- ID: M30541

- Name: Familial Primary Pulmonary Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4807

- Name: Pulmonary Arterial Hypertension

- Relevance: HIGH

- As Found: Pulmonary Arterial Hypertension

### Condition Browse Module - Meshes

- ID: D000081029

- Term: Pulmonary Arterial Hypertension

- ID: D000065627

- Term: Familial Primary Pulmonary Hypertension

- ID: D000006973

- Term: Hypertension

### Misc Info Module

- Version Holder: 2024-05-24
