<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/NCT01700218</url>
  </required_header>
  <id_info>
    <org_study_id>24-537 ex 11/12</org_study_id>
    <nct_id>NCT01700218</nct_id>
  </id_info>
  <brief_title>Integrated Telemonitoring and Nurse Support Evaluation</brief_title>
  <acronym>INTENSE-HF</acronym>
  <official_title>Integrated Telemonitoring and Nurse Support Evaluation in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ludwig Boltzmann Institute for translational heart failure research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AIT Austrian Institute of Technology GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to test a new medical device for optimizing treatment of heart&#xD;
      failure and compare its effect on outcome of patients with a recent hospitalization for&#xD;
      worsening heart failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients after an episode of acute heart failure have an increased risk of rehospitalisation&#xD;
      and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole&#xD;
      telemonitoring system has been able to provide consistent data on a beneficial influence on&#xD;
      prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home&#xD;
      setting of heart failure patients has not been investigated so far.&#xD;
&#xD;
      This study will test a new medical device (software) for optimizing treatment of heart&#xD;
      failure patients and evaluate its impact on outcome of these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality and hospitalization for worsening heart failure</measure>
    <time_frame>12 months</time_frame>
    <description>outcome assessment will be done by a blinded committee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>days alive and out of hospital</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>exploratory endpoint</measure>
    <time_frame>12 months</time_frame>
    <description>The exploratory endpoint will focus on the percentage of optimal dosing (according to current ESC-guidelines) for ACE-inhibitors, angiotensin receptor blockers and beta-blockers</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>telemonitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients in the control arm will not record any vital parameter</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telemonitoring</intervention_name>
    <arm_group_label>telemonitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute systolic heart failure with admission for at least 4 consecutive days&#xD;
&#xD;
          -  treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker,&#xD;
             mineralocorticoid receptor antagonist according to current ESC-guidelines&#xD;
&#xD;
          -  treatment with a loop diuretic&#xD;
&#xD;
          -  stable renal function (eGFR according to MDRD of at least 30ml)&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  minimum age of 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unstable coronary artery disease with revascularisation of any type within the last&#xD;
             two months&#xD;
&#xD;
          -  planned revascularisation or operation for valvular heart disease within the next 6&#xD;
             months&#xD;
&#xD;
          -  planned heart transplantation&#xD;
&#xD;
          -  uncontrolled hypertension&#xD;
&#xD;
          -  active myocarditis&#xD;
&#xD;
          -  malignant disease with a life expectancy of less than 18 months&#xD;
&#xD;
          -  chronic use of high-dose NSAID or COX-2-inhibitors&#xD;
&#xD;
          -  psychiatric disorders that make it unlikely to understand the protocol&#xD;
&#xD;
          -  participation in an other randomized trial&#xD;
&#xD;
          -  inability to operate a smartphone&#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>Friedrich M Fruhwald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Friedrich M Fruhwald, MD</last_name>
    <phone>+43-316-385</phone>
    <phone_ext>12544</phone_ext>
    <email>friedrich.fruhwald@medunigraz.at</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Scherr, MD</last_name>
    <phone>+43-316-385</phone>
    <phone_ext>12544</phone_ext>
    <email>daniel.scherr@medunigraz.at</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Friedrich M Fruhwald, MD</last_name>
      <phone>+43-316-385</phone>
      <phone_ext>12544</phone_ext>
      <email>friedrich.fruhwald@medunigraz.at</email>
    </contact>
    <contact_backup>
      <last_name>Daniel Scherr, MD</last_name>
      <phone>+43-316-385</phone>
      <phone_ext>12544</phone_ext>
      <email>daniel.scherr@medunigraz.at</email>
    </contact_backup>
    <investigator>
      <last_name>Friedrich M Fruhwald, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel Scherr, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <link>
    <url>http://heart.lbg.ac.at</url>
    <description>website of the Ludwig Boltzmann Institute for translational heart failure research</description>
  </link>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>November 23, 2014</last_update_submitted>
  <last_update_submitted_qc>November 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>telemonitoring</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/NCT01700218
org study id: 24-537 ex 11/12
nct id: NCT01700218
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of the study is to test a new medical device for optimizing treatment of heart
      failure and compare its effect on outcome of patients with a recent hospitalization for
      worsening heart failure
Patients after an episode of acute heart failure have an increased risk of rehospitalisation
      and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole
      telemonitoring system has been able to provide consistent data on a beneficial influence on
      prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home
      setting of heart failure patients has not been investigated so far.

      This study will test a new medical device (software) for optimizing treatment of heart
      failure patients and evaluate its impact on outcome of these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: all cause mortality and hospitalization for worsening heart failure
time frame: 12 months
description: outcome assessment will be done by a blinded committee
measure: days alive and out of hospital
time frame: 12 months
measure: exploratory endpoint
time frame: 12 months
description: The exploratory endpoint will focus on the percentage of optimal dosing (according to current ESC-guidelines) for ACE-inhibitors, angiotensin receptor blockers and beta-blockers
arm group label: telemonitoring
arm group type: Other
description: patients in the telemonitoring arm will record vital parameters (blood pressure, heart rate, body weight) and transmit these parameters together with wellbeing and daily dose of heart failure medication
arm group label: control
arm group type: Other
description: patients in the control arm will not record any vital parameter
intervention type: Other
intervention name: telemonitoring
arm group label: telemonitoring
intervention type: Other
intervention name: control
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Friedrich M Fruhwald, MD
role: Principal Investigator
affiliation: Medical University of Graz
last name: Friedrich M Fruhwald, MD
phone: +43-316-385
phone ext: 12544
email: friedrich.fruhwald@medunigraz.at
last name: Daniel Scherr, MD
phone: +43-316-385
phone ext: 12544
email: daniel.scherr@medunigraz.at
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Austria
url: http://heart.lbg.ac.at
description: website of the Ludwig Boltzmann Institute for translational heart failure research
responsible party type: Sponsor
mesh term: Heart Failure