Right Ventricular DysfunctionRIGHT-NetNCT03041337
Right Heart International NETwork During Exercise in Different Clinical Conditions
An observational study of Right Ventricular Dysfunction, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
Trial summary
The aim of this registry will be to compare the pathophysiological response of the morphology and function of the right heart and pulmonary circulation assessed with resting and stress-echocardiography in patients with various cardiovascular diseases, to compare them to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- stress echocardiography
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2015to 1 Jan 2025
- How long will I take part?
- 10 Years
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.
Who may be able to join
- Written informed consent
- Males and females ≥ 18 years' old
- Ability to understand study-specific design and procedures and provide informed consent to the study
Who cannot join
- Inability to perform exercise stress test
- Active smoker
- Pregnancy and/or lactation
- Active malignancy
- End-stage renal disease requiring dialysis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Cardiology and Coronary Care Unit
Cava de' Tirreni, Salerno, 84019
Eduardo Bossone, +390899926241, ebossone@hotmail.com
Francesco Ferrara, +393386762554, francesco.ferrara30@tin.it
About this study
Official title: Morphological and Functional Response of the Right Heart and Pulmonary Circulation
The aim of this registry will be to compare the pathophysiological response of the morphology and function of the right heart and pulmonary circulation assessed with resting and stress-echocardiography in patients with various cardiovascular diseases, to compare them to healthy individuals. The physiological response in healthy individuals as well as elite athletes, defined as athletes participating at national and international competitions, will also be evaluated. Patients will be enrolled both prospectively as well as retrospectively and the will be evaluated by resting and stress echocardiography, which are part of the routine clinical practice.
All clinical outcome measures will be collected as part of routine examinations. The measurements will include systolic and diastolic pump function of the right and left ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters among different groups will be performed. Other optional assessments will include: exercise capacity assessed with 6-minute walking distance, World Health Organization functional class (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be evaluated at baseline and each year with the aforementioned procedures according to the sites clinical routine.
Read the detailed description
Patients will be evaluated with a routinely performed resting and stress echocardiography. Moreover, physical examination and ECG will be performed and past medical history will be collected. Optional procedures comprise of quality of life assessment (SF-36 questionnaire), six minute walking distance (6MWD), cardiopulmonary exercise testing (CPET), routine laboratory including biochemical work-up.
Comparison among different cohorts of patients with regards to right heart morphology and function at rest, assessed during a routinely performed resting and stress echography. The following parameters will be evaluated:
- Right ventricular (RV) diameters
- RV free wall thickness
- End-diastolic and end-systolic left ventricular volumes and ejection fraction
- Right atrial (RA) area
- End-diastolic and end-systolic RV area and % shortening of the areas of the right ventricle
- Tricuspid regurgitation velocity (TRV) and severity
- Tricuspid annular plane systolic excursion (TAPSE)
- Inferior vena cava diameter and % of collapsibility
- TAPSE at peak exercise and after 5 minutes recovery
- TRV at peak exercise and after 5 minutes recovery
- RV end-diastolic and end-systolic area and % shortening of the areas at peak exercise and after 5 minutes recovery
- RA area at peak exercise and after 5 minutes recovery
- Left ventricular end-diastolic and end-systolic volume and ejection fraction at peak exercise and after 5 minutes recovery
- Left ventricular eccentricity index at peak exercise and after 5 minutes recovery
- Conditions
- Right Ventricular Dysfunction
- Being tested
- stress echocardiography
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress echocardiographyDiagnostic test
stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes.
The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography. Receives: Diagnostic Test: stress echocardiography | |
| cardio-respiratory diseases | patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography. Receives: Diagnostic Test: stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Ventricle contractile reserve
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
Measured: ten years
Secondary outcomes (4)
All-cause Mortality
All cause of mortality
Measured: ten years
Cardiovascular Mortality
all cardiovascular mortality
Measured: ten years
RV internal end-diastolic diameters
measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
Measured: ten years
tricuspid annular plane systolic excursion (TAPSE)
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Jun 2015
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Bossone, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Investigators
- Eduardo Bossone, Study chair, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041337
- Sponsor's protocol ID
- RIGHT-Net
- Acronym
- RIGHT-Net
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Luca M, Ferrara F, Gargani L, Argiento P, Bandera F, Carbone A, Castaldo R, D'Agostino A, D'Alto M, D'Andrea A, D'Assante R, Franzese M, Giardino F, Grunig E, Kasprzak JD, Limongelli G, Passaro E, Pugliese NR, Rega S, Schiavo A, Vriz O, Wierzbowska-Drabik K, Cittadini A, Naeije R, Bossone E, Marra AM; RIGHT Heart International NETwork. Exercise Doppler Echocardiography of the Right Heart and Pulmonary Circulation in Patients With Cardiovascular Risk Factors: Observations From the RIGHT Heart International NETwork (RIGHT-NET). Chest. 2025 Dec;168(6):1460-1470. doi: 10.1016/j.chest.2025.06.020. Epub 2025 Jun 19.
PubMed 40543748Gargani L, Pugliese NR, De Biase N, Mazzola M, Agoston G, Arcopinto M, Argiento P, Armstrong WF, Bandera F, Cademartiri F, Carbone A, Castaldo R, Citro R, Cocchia R, Codullo V, D'Alto M, D'Andrea A, Douschan P, Fabiani I, Ferrara F, Franzese M, Frumento P, Ghio S, Grunig E, Guazzi M, Kasprzak JD, Kolias T, Kovacs G, La Gerche A, Limogelli G, Marra AM, Matucci-Cerinic M, Mauro C, Moreo A, Pratali L, Ranieri B, Rega S, Rudski L, Saggar R, Salzano A, Serra W, Stanziola AA, Vannan MA, Voilliot D, Vriz O, Wierzbowska-Drabik K, Cittadini A, Naeije R, Bossone E; RIGHT Heart International NETwork (RIGHT-NET) Investigators. Exercise Stress Echocardiography of the Right Ventricle and Pulmonary Circulation. J Am Coll Cardiol. 2023 Nov 21;82(21):1973-1985. doi: 10.1016/j.jacc.2023.09.807.
PubMed 37968015
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Functional Response of the Right Heart and Pulmonary Circulation
- ClinicalTrials.gov ID
- NCT03041337
- Acronym / sponsor ID
- RIGHT-Net / RIGHT-Net
- Conditions
- Right Ventricular Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 Feb 2017 (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.
The aim of this registry will be to compare the pathophysiological response of the morphology and function of the right heart and pulmonary circulation assessed with resting and stress-echocardiography in patients with various cardiovascular diseases, to compare them to healthy individuals. The physiological response in healthy individuals as well as elite athletes, defined as athletes participating at national and international competitions, will also be evaluated. Patients will be enrolled both prospectively as well as retrospectively and the will be evaluated by resting and stress echocardiography, which are part of the routine clinical practice.
All clinical outcome measures will be collected as part of routine examinations. The measurements will include systolic and diastolic pump function of the right and left ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters among different groups will be performed. Other optional assessments will include: exercise capacity assessed with 6-minute walking distance, World Health Organization functional class (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be evaluated at baseline and each year with the aforementioned procedures according to the sites clinical routine.
Detailed description
Patients will be evaluated with a routinely performed resting and stress echocardiography. Moreover, physical examination and ECG will be performed and past medical history will be collected. Optional procedures comprise of quality of life assessment (SF-36 questionnaire), six minute walking distance (6MWD), cardiopulmonary exercise testing (CPET), routine laboratory including biochemical work-up.
Comparison among different cohorts of patients with regards to right heart morphology and function at rest, assessed during a routinely performed resting and stress echography. The following parameters will be evaluated:
- Right ventricular (RV) diameters
- RV free wall thickness
- End-diastolic and end-systolic left ventricular volumes and ejection fraction
- Right atrial (RA) area
- End-diastolic and end-systolic RV area and % shortening of the areas of the right ventricle
- Tricuspid regurgitation velocity (TRV) and severity
- Tricuspid annular plane systolic excursion (TAPSE)
- Inferior vena cava diameter and % of collapsibility
- TAPSE at peak exercise and after 5 minutes recovery
- TRV at peak exercise and after 5 minutes recovery
- RV end-diastolic and end-systolic area and % shortening of the areas at peak exercise and after 5 minutes recovery
- RA area at peak exercise and after 5 minutes recovery
- Left ventricular end-diastolic and end-systolic volume and ejection fraction at peak exercise and after 5 minutes recovery
- Left ventricular eccentricity index at peak exercise and after 5 minutes recovery
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Diagnostic Test: stress echocardiographyCohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography. |
| cardio-respiratory diseases | – | Diagnostic Test: stress echocardiographypatients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.
Key inclusion criteria (3 listed)
- Written informed consent
- Males and females ≥ 18 years' old
- Ability to understand study-specific design and procedures and provide informed consent to the study
Key exclusion criteria (5 listed)
- Inability to perform exercise stress test
- Active smoker
- Pregnancy and/or lactation
- Active malignancy
- End-stage renal disease requiring dialysis
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 |
|---|---|---|
| stress echocardiographystress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes. The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations | Diagnostic test | Healthy subjects, cardio-respiratory diseases |
Primary outcome
Right Ventricle contractile reserve
Time frame: ten years
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
4 secondary outcomes
All-cause Mortality
Time frame: ten years
Cardiovascular Mortality
Time frame: ten years
RV internal end-diastolic diameters
Time frame: ten years
tricuspid annular plane systolic excursion (TAPSE)
Time frame: ten years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
- Derived from this study: PubMed 40543748De Luca M, Ferrara F, Gargani L, Argiento P, Bandera F, Carbone A, Castaldo R, D'Agostino A, D'Alto M, D'Andrea A, D'Assante R, Franzese M, Giardino F, Grunig E, Kasprzak JD, Limongelli G, Passaro E, Pugliese NR, Rega S, Schiavo A, Vriz O, Wierzbowska-Drabik K, Cittadini A, Naeije R, Bossone E, Marra AM; RIGHT Heart International NETwork. Exercise Doppler Echocardiography of the Right Heart and Pulmonary Circulation in Patients With Cardiovascular Risk Factors: Observations From the RIGHT Heart International NETwork (RIGHT-NET). Chest. 2025 Dec;168(6):1460-1470. doi: 10.1016/j.chest.2025.06.020. Epub 2025 Jun 19.
- Derived from this study: PubMed 37968015Gargani L, Pugliese NR, De Biase N, Mazzola M, Agoston G, Arcopinto M, Argiento P, Armstrong WF, Bandera F, Cademartiri F, Carbone A, Castaldo R, Citro R, Cocchia R, Codullo V, D'Alto M, D'Andrea A, Douschan P, Fabiani I, Ferrara F, Franzese M, Frumento P, Ghio S, Grunig E, Guazzi M, Kasprzak JD, Kolias T, Kovacs G, La Gerche A, Limogelli G, Marra AM, Matucci-Cerinic M, Mauro C, Moreo A, Pratali L, Ranieri B, Rega S, Rudski L, Saggar R, Salzano A, Serra W, Stanziola AA, Vannan MA, Voilliot D, Vriz O, Wierzbowska-Drabik K, Cittadini A, Naeije R, Bossone E; RIGHT Heart International NETwork (RIGHT-NET) Investigators. Exercise Stress Echocardiography of the Right Ventricle and Pulmonary Circulation. J Am Coll Cardiol. 2023 Nov 21;82(21):1973-1985. doi: 10.1016/j.jacc.2023.09.807.
- Individual participant dataSharing planned: No
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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.
Eduardo Bossone study chair
Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
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 Right Ventricular Dysfunction, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Bossone, Chief of Cardiology (+390899926241, ebossone@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Ventricle contractile reserve (time frame: ten years). 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 NCT03041337, which also lists 2 linked publications.
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 2 Feb 2017.