Clinical trial NCT03041337: Right Heart International NETwork During Exercise in Different Clinical Conditions
Official title: Morphological and Functional Response of the Right Heart and Pulmonary Circulation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Right Ventricular Dysfunction
Lead sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.

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

Eligibility criteria: 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

Primary outcomes:
measure: Right Ventricle contractile reserve
timeFrame: ten years
Secondary outcomes:
measure: All-cause Mortality
timeFrame: ten years
measure: Cardiovascular Mortality
timeFrame: ten years
measure: RV internal end-diastolic diameters
timeFrame: ten years
measure: tricuspid annular plane systolic excursion (TAPSE)
timeFrame: ten years
Other outcomes:
Locations:
city: Cava de' Tirreni
country: Italy
facility: Cardiology and Coronary Care Unit
state: Salerno
Study officials:
affiliation: Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
name: Eduardo Bossone
role: STUDY_CHAIR
References: