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Right Heart International NETwork During Exercise in Different Clinical Conditions

Morphological and Functional Response of the Right Heart and Pulmonary Circulation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03041337
Acronym
RIGHT-Net
Enrollment
1000
Registered
2017-02-02
Start date
2015-06-01
Completion date
2025-01-01
Last updated
2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right Ventricular Dysfunction

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.

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

Interventions

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

Sponsors

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Right Ventricle contractile reserveten yearsDifference of tricuspid regurgitation velocity at rest to peak exercise (m/s)

Secondary

MeasureTime frameDescription
All-cause Mortalityten yearsAll cause of mortality
Cardiovascular Mortalityten yearsall cardiovascular mortality
RV internal end-diastolic diametersten yearsmeasurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
tricuspid annular plane systolic excursion (TAPSE)ten yearstricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm

Countries

Italy

Contacts

Primary ContactEduardo Bossone, Chief of Cardiology
ebossone@hotmail.com+390899926241
Backup ContactAlberto M. Marra, MD
alberto.marra@med.uni-heidelberg.de+4915207559254

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026