Pulmonary Arterial HypertensionHTP3SNCT02799979
3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- 3D right ventricular imaging echocardiographic
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2014to 2 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pulmonary hypertension diagnosed
Who may be able to join
- Patients > 18 years old
- Pulmonary hypertension diagnosed by right heart catheterization
- Informed consent obtained
- Affiliation to the French national health insurance
Who cannot join
- Associated significant left heart disease
- Sub-optimal acoustic windows
- Patient unable to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
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
- Pulmonary Arterial Hypertension
- Being tested
- 3D right ventricular imaging echocardiographic
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D right ventricular imaging echocardiographicDevice
Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.
| Study group | Role | What they receive |
|---|---|---|
| Case | Echocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months Receives: Device: 3D right ventricular imaging echocardiographic | |
| Control | Echocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline Receives: Device: 3D right ventricular imaging echocardiographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death from any cause
Description of the number of death during the study
Measured: Baseline to 24 months
Secondary outcomes (2)
Number of Hospitalisation
Description of the number of hospitalisation for worsening of pulmonary arterial hypertension
Measured: Baseline to 24 months
3D right ventricular imaging echocardiographic
Analyse the data of 3D right ventricular (RV), ejection fraction, RV telediastolic and telesystolic volume, 3D RV area strain (%)
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start10 Oct 2014
- Primary completion20 Oct 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PAMELA MOCERI, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799979
- Sponsor's protocol ID
- 14-AOI-08
- Acronym
- HTP3S
- Status last verified
- Jun 2026
- First submitted
- 30 May 2016
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36265185
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02799979
- Acronym / sponsor ID
- HTP3S / 14-AOI-08
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Oct 2014 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Device: 3D right ventricular imaging echocardiographicEchocardiographic data : 3D right ventricular imaging on 100 pulmonary hypertension patients at Baseline and after six months |
| Control | – | Device: 3D right ventricular imaging echocardiographicEchocardiographic data : 3D right ventricular Imaging on 50 patients without pulmonary hypertension only at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary hypertension diagnosed
Key inclusion criteria (4 listed)
- Patients > 18 years old
- Pulmonary hypertension diagnosed by right heart catheterization
- Informed consent obtained
- Affiliation to the French national health insurance
Key exclusion criteria (3 listed)
- Associated significant left heart disease
- Sub-optimal acoustic windows
- Patient unable to attend follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D right ventricular imaging echocardiographicEchocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months. | Device | Case, Control |
Primary outcome
Number of death from any cause
Time frame: Baseline to 24 months
Description of the number of death during the study
2 secondary outcomes
Number of Hospitalisation
Time frame: Baseline to 24 months
3D right ventricular imaging echocardiographic
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 36265185Moceri 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAMELA MOCERI, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death from any cause (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.