Right Heart International NETwork During Exercise in Different Clinical Conditions (RIGHT-Net)

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.

Study Overview

• Status: Recruiting
• Conditions: Right Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: stress echocardiography

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Eduardo Bossone, Chief of Cardiology; Phone Number: +390899926241; Email: ebossone@hotmail.com
• Study Contact Backup: Name: Alberto M. Marra, MD; Phone Number: +4915207559254; Email: alberto.marra@med.uni-heidelberg.de

Study Locations

• Italy
  • Salerno
    • Cava de' Tirreni, Salerno, Italy, 84019
      • Recruiting
      • Cardiology and Coronary Care Unit
      • Contact: Eduardo Bossone; Phone Number: +390899926241; Email: ebossone@hotmail.com
      • Contact: Francesco Ferrara; Phone Number: +393386762554; Email: francesco.ferrara30@tin.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
cardio-respiratory diseases; patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.	Diagnostic test: stress echocardiography; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right Ventricle contractile reserve	Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)	ten years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	All cause of mortality	ten years
Cardiovascular Mortality	all cardiovascular mortality	ten years
RV internal end-diastolic diameters	measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm	ten years
tricuspid annular plane systolic excursion (TAPSE)	tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm	ten years

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Investigators: Study Chair: Eduardo Bossone, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: RIGHT-Net

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No