Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041337
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Bossone, 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.


Condition or disease Intervention/treatment
Right Ventricular Dysfunction 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

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Morphological and Functional Response of the Right Heart and Pulmonary Circulation
Actual Study Start Date : June 1, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2025

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





Primary Outcome Measures :
  1. Right Ventricle contractile reserve [ Time Frame: ten years ]
    Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)


Secondary Outcome Measures :
  1. All-cause Mortality [ Time Frame: ten years ]
    All cause of mortality

  2. Cardiovascular Mortality [ Time Frame: ten years ]
    all cardiovascular mortality

  3. RV internal end-diastolic diameters [ Time Frame: ten years ]
    measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm

  4. tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: ten years ]
    tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041337


Contacts
Layout table for location contacts
Contact: Eduardo Bossone, Chief of Cardiology +390899926241 ebossone@hotmail.com
Contact: Alberto M. Marra, MD +4915207559254 alberto.marra@med.uni-heidelberg.de

Locations
Layout table for location information
Italy
Cardiology and Coronary Care Unit Recruiting
Cava de' Tirreni, Salerno, Italy, 84019
Contact: Eduardo Bossone    +390899926241    ebossone@hotmail.com   
Contact: Francesco Ferrara    +393386762554    francesco.ferrara30@tin.it   
Sponsors and Collaborators
Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Investigators
Layout table for investigator information
Study Chair: Eduardo Bossone Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
Additional Information:

Layout table for additonal information
Responsible Party: Eduardo Bossone, Director of Cardiology and Coronary Care Unit, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
ClinicalTrials.gov Identifier: NCT03041337    
Other Study ID Numbers: RIGHT-Net
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Ventricular Dysfunction
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases