<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03041337</url>
  </required_header>
  <id_info>
    <org_study_id>RIGHT-Net</org_study_id>
    <nct_id>NCT03041337</nct_id>
  </id_info>
  <brief_title>Right Heart International NETwork During Exercise in Different Clinical Conditions</brief_title>
  <acronym>RIGHT-Net</acronym>
  <official_title>Morphological and Functional Response of the Right Heart and Pulmonary Circulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this registry will be to compare the pathophysiological response of the morphology&#xD;
      and function of the right heart and pulmonary circulation assessed with resting and&#xD;
      stress-echocardiography in patients with various cardiovascular diseases, to compare them to&#xD;
      healthy individuals. The physiological response in healthy individuals as well as elite&#xD;
      athletes, defined as athletes participating at national and international competitions, will&#xD;
      also be evaluated. Patients will be enrolled both prospectively as well as retrospectively&#xD;
      and the will be evaluated by resting and stress echocardiography, which are part of the&#xD;
      routine clinical practice.&#xD;
&#xD;
      All clinical outcome measures will be collected as part of routine examinations. The&#xD;
      measurements will include systolic and diastolic pump function of the right and left&#xD;
      ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters&#xD;
      among different groups will be performed. Other optional assessments will include: exercise&#xD;
      capacity assessed with 6-minute walking distance, World Health Organization functional class&#xD;
      (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be&#xD;
      evaluated at baseline and each year with the aforementioned procedures according to the sites&#xD;
      clinical routine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be evaluated with a routinely performed resting and stress echocardiography.&#xD;
      Moreover, physical examination and ECG will be performed and past medical history will be&#xD;
      collected. Optional procedures comprise of quality of life assessment (SF-36 questionnaire),&#xD;
      six minute walking distance (6MWD), cardiopulmonary exercise testing (CPET), routine&#xD;
      laboratory including biochemical work-up.&#xD;
&#xD;
      Comparison among different cohorts of patients with regards to right heart morphology and&#xD;
      function at rest, assessed during a routinely performed resting and stress echography. The&#xD;
      following parameters will be evaluated:&#xD;
&#xD;
        -  Right ventricular (RV) diameters&#xD;
&#xD;
        -  RV free wall thickness&#xD;
&#xD;
        -  End-diastolic and end-systolic left ventricular volumes and ejection fraction&#xD;
&#xD;
        -  Right atrial (RA) area&#xD;
&#xD;
        -  End-diastolic and end-systolic RV area and % shortening of the areas of the right&#xD;
           ventricle&#xD;
&#xD;
        -  Tricuspid regurgitation velocity (TRV) and severity&#xD;
&#xD;
        -  Tricuspid annular plane systolic excursion (TAPSE)&#xD;
&#xD;
        -  Inferior vena cava diameter and % of collapsibility&#xD;
&#xD;
        -  TAPSE at peak exercise and after 5 minutes recovery&#xD;
&#xD;
        -  TRV at peak exercise and after 5 minutes recovery&#xD;
&#xD;
        -  RV end-diastolic and end-systolic area and % shortening of the areas at peak exercise&#xD;
           and after 5 minutes recovery&#xD;
&#xD;
        -  RA area at peak exercise and after 5 minutes recovery&#xD;
&#xD;
        -  Left ventricular end-diastolic and end-systolic volume and ejection fraction at peak&#xD;
           exercise and after 5 minutes recovery&#xD;
&#xD;
        -  Left ventricular eccentricity index at peak exercise and after 5 minutes recovery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Right Ventricle contractile reserve</measure>
    <time_frame>ten years</time_frame>
    <description>Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>ten years</time_frame>
    <description>All cause of mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Mortality</measure>
    <time_frame>ten years</time_frame>
    <description>all cardiovascular mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RV internal end-diastolic diameters</measure>
    <time_frame>ten years</time_frame>
    <description>measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tricuspid annular plane systolic excursion (TAPSE)</measure>
    <time_frame>ten years</time_frame>
    <description>tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Right Ventricular Dysfunction</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cardio-respiratory diseases</arm_group_label>
    <description>patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>stress echocardiography</intervention_name>
    <description>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.&#xD;
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</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>cardio-respiratory diseases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients and healthy subjects will be enrolled both retrospectively as well as&#xD;
        prospectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Males and females ≥ 18 years' old&#xD;
&#xD;
          -  Ability to understand study-specific design and procedures and provide informed&#xD;
             consent to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to perform exercise stress test&#xD;
&#xD;
          -  Active smoker&#xD;
&#xD;
          -  Pregnancy and/or lactation&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  End-stage renal disease requiring dialysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eduardo Bossone</last_name>
    <role>Study Chair</role>
    <affiliation>Azienda Universitaria Ospedaliera &quot;S. Giovanni e Ruggi d'Aragona&quot;</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eduardo Bossone, Chief of Cardiology</last_name>
    <phone>+390899926241</phone>
    <email>ebossone@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alberto M. Marra, MD</last_name>
    <phone>+4915207559254</phone>
    <email>alberto.marra@med.uni-heidelberg.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiology and Coronary Care Unit</name>
      <address>
        <city>Cava de' Tirreni</city>
        <state>Salerno</state>
        <zip>84019</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eduardo Bossone</last_name>
      <phone>+390899926241</phone>
      <email>ebossone@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Francesco Ferrara</last_name>
      <phone>+393386762554</phone>
      <email>francesco.ferrara30@tin.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona</investigator_affiliation>
    <investigator_full_name>Eduardo Bossone</investigator_full_name>
    <investigator_title>Director of Cardiology and Coronary Care Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Dysfunction</mesh_term>
    <mesh_term>Ventricular Dysfunction, Right</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041337
org study id: RIGHT-Net
nct id: NCT03041337
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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
observational model: Other
time perspective: Prospective
measure: Right Ventricle contractile reserve
time frame: ten years
description: Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
measure: All-cause Mortality
time frame: ten years
description: All cause of mortality
measure: Cardiovascular Mortality
time frame: ten years
description: all cardiovascular mortality
measure: RV internal end-diastolic diameters
time frame: ten years
description: measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
measure: tricuspid annular plane systolic excursion (TAPSE)
time frame: ten years
description: tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
arm group label: Healthy subjects
description: Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography.
arm group label: cardio-respiratory diseases
description: patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.
intervention type: Diagnostic Test
intervention name: stress echocardiography
description: 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
arm group label: Healthy subjects
arm group label: cardio-respiratory diseases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eduardo Bossone
role: Study Chair
affiliation: Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
last name: Eduardo Bossone, Chief of Cardiology
phone: +390899926241
email: ebossone@hotmail.com
last name: Alberto M. Marra, MD
phone: +4915207559254
email: alberto.marra@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
investigator full name: Eduardo Bossone
investigator title: Director of Cardiology and Coronary Care Unit
mesh term: Ventricular Dysfunction
mesh term: Ventricular Dysfunction, Right
sharing ipd: No