Right Heart International NETwork During Exercise in Different Clinical Conditions

Right Ventricular Dysfunction Clinical Trial

— RIGHT-Net  

Official title:

Morphological and Functional Response of the Right Heart and Pulmonary Circulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041337
• Other study ID #: RIGHT-Net
• Status: Recruiting
• Phase: N/A
• First received: January 25, 2017
• Last updated: January 31, 2017
• Start date: June 1, 2015
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2017
• Source: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
• Contact: Eduardo Bossone, Chief of Cardiology
• Phone: +390899926241
• Email: ebossone[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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

Locations

Country	Name	City	State
Italy	Cardiology and Coronary Care Unit	Cava de' Tirreni	Salerno

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right Ventricle contractile reserve	Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)	ten years
Secondary	All-cause Mortality	All cause of mortality	ten years
Secondary	Cardiovascular Mortality	all cardiovascular mortality	ten years
Secondary	RV internal end-diastolic diameters	measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm	ten years
Secondary	tricuspid annular plane systolic excursion (TAPSE)	tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm	ten years