Clinical Trials Logo
  1. Home
  2. Pulmonary Arterial Hypertension
  3. NCT02799979
  4. Details
NCT02799979 Clinical Trial

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— HTP3S  

Official title:
3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02799979
Other study ID # 14-AOI-08
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2016
Last updated October 3, 2017
Start date October 2014
Est. completion date June 2019

Study information
Verified date October 2017
Source Centre Hospitalier Universitaire de Nice
Contact PAMELA MOCERI, MD
Phone 4 92 03 77 34
Email moceri.p@chu-nice.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2019
Est. primary completion date October 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Hopital Pasteur - Chu Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of death from any cause Description of the number of death during the study Baseline to 24 months
Secondary Number of Hospitalisation Description of the number of hospitalisation for worsening of pulmonary arterial hypertension Baseline to 24 months
Secondary 3D right ventricular imaging echocardiographic Analyse the data of 3D right ventricular (RV), ejection fraction, RV telediastolic and telesystolic volume, 3D RV area strain (%) Baseline and 6 months
See also
  Status Clinical Trial Phase
Completed NCT04076241 - Effects of Adding Yoga Respiratory Training to Osteopathic Manipulative Treatment in Pulmonary Arterial Hypertension N/A
Completed NCT05521113 - Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension
Recruiting NCT04972656 - Treatment With Ambrisentan in Patients With Borderline Pulmonary Arterial Hypertension N/A
Completed NCT04908397 - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension Phase 1
Active, not recruiting NCT03288025 - Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) N/A
Completed NCT01959815 - Novel Screening Strategies for Scleroderma PAH
Recruiting NCT04266197 - Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study Phase 2
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Terminated NCT02060487 - Effects of Oral Sildenafil on Mortality in Adults With PAH Phase 4
Terminated NCT02253394 - The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study Phase 4
Withdrawn NCT02958358 - FDG Uptake and Lung Blood Flow in PAH Before and After Treatment With Ambrisentan N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Not yet recruiting NCT01649739 - Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost Phase 4
Withdrawn NCT01723371 - Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children Phase 1/Phase 2
Unknown status NCT01712997 - Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients Phase 3
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01165047 - Nitric Oxide, GeNO Nitrosyl Delivery System Phase 2
Completed NCT00902174 - Imatinib (QTI571) in Pulmonary Arterial Hypertension Phase 3
Completed NCT00963027 - Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil Phase 1