<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/NCT01723865</url>
  </required_header>
  <id_info>
    <org_study_id>Effect</org_study_id>
    <nct_id>NCT01723865</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of Remote Monitoring in the Management of Heart Failure</brief_title>
  <acronym>EFFECT</acronym>
  <official_title>Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&amp;CRT-D.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Effect Group, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Effect Group, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients&#xD;
      with heart failure having an ICD-CRT implanted.&#xD;
&#xD;
      Study purpose The purpose of this study is to test the hypothesis that the monitoring of&#xD;
      specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical&#xD;
      course of patients with heart failure.&#xD;
&#xD;
      Study design This is a prospective observational study, comparing clinical course of patients&#xD;
      with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This&#xD;
      study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring&#xD;
      system (with or without weight and pressure external sensors) or followed by conventional&#xD;
      ambulatory visits.&#xD;
&#xD;
      Primary endpoints The primary endpoint of this study is to document no superiority of&#xD;
      unplanned hospital access for cardiac reasons (included access to the emergency units ) or&#xD;
      death for cardiovascular causes in remote monitoring group (with or without weight and&#xD;
      pressure external sensors) compared to conventional follow-up (usual care group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated&#xD;
      remote monitoring system (RPM) in the management of patients with heart failure and implanted&#xD;
      with ICDs and CRT-D.&#xD;
&#xD;
      The clinical benefit will be assessed by:&#xD;
&#xD;
        -  Increased cardiovascular events (death, myocardial infarction, hospitalization).&#xD;
&#xD;
        -  Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular&#xD;
           tachycardia or ventricular fibrillation.&#xD;
&#xD;
        -  Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life&#xD;
           questionnaire.&#xD;
&#xD;
      The primary endpoint of this study is to estimate the incidence (and its accuracy) of the&#xD;
      first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular&#xD;
      causes in the group monitored using RPM (with or without external sensors) and in the group&#xD;
      management via conventional follow-up (Usual Care).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>unplanned hospitalizations or death</measure>
    <time_frame>1 year</time_frame>
    <description>unplanned hospitalization or for cardiac reasons or death for cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All reasons hospitalizations</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for cardiac causes</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventricular tachycardia or fibrillation</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of ventricular tachycardia or fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of atrial fibrillation episodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart transplantation</measure>
    <time_frame>1 year</time_frame>
    <description>heart transplantation occurence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost for National Health System (NHS)</measure>
    <time_frame>1 year</time_frame>
    <description>Estimate the total cost for the NHS for the management of heart failure patients implanted with ICD-CRT, monitored or not with a remote monitoring system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate the clinical benefit by means of 6-minute walking test, use of medications and changes of echocardiographic parameters, between the patients followed by conventional visits and patients followed by remote controls (with or without external sensors).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Autonomic activity</measure>
    <time_frame>1 year</time_frame>
    <description>Indexes of autonomic activity such as th mean of standard deviations of RR intervals calculated on 5 minutes intervals (SDANN), activity log and &quot;footprint&quot;, will be compared in patients followed by conventional visits of by remote controls.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">988</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <description>Patients with heart failure having an ICD-CRT implanted, followed by conventional visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remote Monitoring</arm_group_label>
    <description>Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both gender implanted or eligible for implant with ICD-CRT-D, for heart failure&#xD;
        treatment and/or primary prevention of sudden death, followed or not by a remote monitoring&#xD;
        system.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects &gt;18 years&#xD;
&#xD;
          -  patients implanted or eligible for implant with ICD-CRT-D, accordingly with guidelines&#xD;
             of the centers, for heart failure treatment and/or primary prevention of sudden death&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of clinically overt heart failure.&#xD;
&#xD;
          -  Myocardial infarction within 2 months before enrolment.&#xD;
&#xD;
          -  Significant concurrent illness or condition severely limiting life expectancy.&#xD;
&#xD;
          -  Any surgical or medical condition which, at the discretion of the investigator, place&#xD;
             the patient at higher risk from his/her participation in the study, or are likely to&#xD;
             prevent the patient from complying with the requirements of the study or completing&#xD;
             the trial period.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the last 2 years.&#xD;
&#xD;
          -  Inability to communicate and comply with all study requirements including the&#xD;
             unwillingness or inability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianfranco Buja, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedali riuniti di Ancona</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospededaliero Universitaria Policlinico</name>
      <address>
        <city>Bari</city>
        <zip>70125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Venere</name>
      <address>
        <city>Bari</city>
        <zip>70131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S.Spirito</name>
      <address>
        <city>Casale MOnferrato</city>
        <zip>15033</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ferrari Hospital</name>
      <address>
        <city>Casarano</city>
        <zip>73042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Ferrari</name>
      <address>
        <city>Castrovillari</city>
        <zip>87012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico V,Emanuele - Cardiologia Ferrarotto</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Istituto San Raffaele G.Giglio</name>
      <address>
        <city>Cefalù</city>
        <zip>90015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dep. of Cardiology, Civic Hospital</name>
      <address>
        <city>Ciriè</city>
        <zip>10073</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vito Fazzi Hospital</name>
      <address>
        <city>Lecce</city>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Civic Hospital</name>
      <address>
        <city>Moncalieri</city>
        <zip>10024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale dei Colli - Monaldi</name>
      <address>
        <city>Napoli</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Mediterranea</name>
      <address>
        <city>Napoli</city>
        <zip>80122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale dei Colli, Monaldi</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. Cardiology, S. Cuore Hospital</name>
      <address>
        <city>Negrar</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Remote Monitoring</keyword>
  <keyword>ICD</keyword>
  <keyword>Follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723865
org study id: Effect
nct id: NCT01723865
lead sponsor: 
has dmc: No
This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients
      with heart failure having an ICD-CRT implanted.

      Study purpose The purpose of this study is to test the hypothesis that the monitoring of
      specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical
      course of patients with heart failure.

      Study design This is a prospective observational study, comparing clinical course of patients
      with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This
      study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring
      system (with or without weight and pressure external sensors) or followed by conventional
      ambulatory visits.

      Primary endpoints The primary endpoint of this study is to document no superiority of
      unplanned hospital access for cardiac reasons (included access to the emergency units ) or
      death for cardiovascular causes in remote monitoring group (with or without weight and
      pressure external sensors) compared to conventional follow-up (usual care group).
Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated
      remote monitoring system (RPM) in the management of patients with heart failure and implanted
      with ICDs and CRT-D.

      The clinical benefit will be assessed by:

        -  Increased cardiovascular events (death, myocardial infarction, hospitalization).

        -  Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular
           tachycardia or ventricular fibrillation.

        -  Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life
           questionnaire.

      The primary endpoint of this study is to estimate the incidence (and its accuracy) of the
      first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular
      causes in the group monitored using RPM (with or without external sensors) and in the group
      management via conventional follow-up (Usual Care).
observational model: Case-Control
time perspective: Prospective
measure: unplanned hospitalizations or death
time frame: 1 year
description: unplanned hospitalization or for cardiac reasons or death for cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).
measure: All reasons hospitalizations
time frame: 1 year
measure: Hospitalization for cardiac causes
time frame: 1 year
measure: Myocardial infarction
time frame: 1 year
description: Incidence of myocardial infarction
measure: Ventricular tachycardia or fibrillation
time frame: 1 year
description: Incidence of ventricular tachycardia or fibrillation
measure: Atrial fibrillation
time frame: 1 year
description: Incidence of atrial fibrillation episodes.
measure: Heart transplantation
time frame: 1 year
description: heart transplantation occurence
measure: Cost for National Health System (NHS)
time frame: 1 year
description: Estimate the total cost for the NHS for the management of heart failure patients implanted with ICD-CRT, monitored or not with a remote monitoring system.
measure: Clinical benefit
time frame: 1 year
description: Evaluate the clinical benefit by means of 6-minute walking test, use of medications and changes of echocardiographic parameters, between the patients followed by conventional visits and patients followed by remote controls (with or without external sensors).
measure: Autonomic activity
time frame: 1 year
description: Indexes of autonomic activity such as th mean of standard deviations of RR intervals calculated on 5 minutes intervals (SDANN), activity log and "footprint", will be compared in patients followed by conventional visits of by remote controls.
arm group label: Conventional
description: Patients with heart failure having an ICD-CRT implanted, followed by conventional visits.
arm group label: Remote Monitoring
description: Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gianfranco Buja, MD
role: Principal Investigator
affiliation: University of Padova
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Heart Failure