NCT03041337

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

4.6 years

First QC Date

January 25, 2017

Last Update Submit

January 31, 2017

Conditions

Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Right Ventricle contractile reserve

    Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)

    ten years

Secondary Outcomes (4)

  • All-cause Mortality

    ten years

  • Cardiovascular Mortality

    ten years

  • RV internal end-diastolic diameters

    ten years

  • tricuspid annular plane systolic excursion (TAPSE)

    ten years

Study Arms (2)

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.

Diagnostic Test: stress echocardiography

cardio-respiratory diseases

patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.

Diagnostic Test: stress echocardiography

Interventions

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

Healthy subjectscardio-respiratory diseases

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.

You may qualify if:

  • Written informed consent
  • Males and females ≥ 18 years' old
  • Ability to understand study-specific design and procedures and provide informed consent to the study

You may not qualify if:

  • Inability to perform exercise stress test
  • Active smoker
  • Pregnancy and/or lactation
  • Active malignancy
  • End-stage renal disease requiring dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology and Coronary Care Unit

Cava de' Tirreni, Salerno, 84019, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40543748DERIVED

  • Gargani 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.

    PMID: 37968015DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Interventions

Echocardiography, Stress

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Eduardo Bossone

    Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"

    STUDY CHAIR

Central Study Contacts

Eduardo Bossone, Chief of Cardiology

CONTACT

+390899926241ebossone@hotmail.com

Alberto M. Marra, MD

CONTACT

+4915207559254alberto.marra@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology and Coronary Care Unit

Study Record Dates

First Submitted

January 25, 2017

First Posted

February 2, 2017

Study Start

June 1, 2015

Primary Completion

January 1, 2020

Study Completion

January 1, 2025

Last Updated

February 2, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)