Right Heart International NETwork During Exercise in Different Clinical Conditions

Recruiting

• Conditions: Right Ventricular Dysfunction
• Interventions: Diagnostic Test: stress echocardiography

• Registration Number: NCT03041337
• Lead Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

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

Study Timeline

• Study Start: 2015-06-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02
• Primary Completion: 2020-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	stress echocardiography	Cohort 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	stress echocardiography	patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.

Primary Outcome Measures

Name	Time	Method
Right Ventricle contractile reserve	ten years	Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiology and Coronary Care Unit; 🇮🇹 Cava de' Tirreni, Salerno, Italy