<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/NCT03282136</url>
  </required_header>
  <id_info>
    <org_study_id>University of Campania</org_study_id>
    <nct_id>NCT03282136</nct_id>
  </id_info>
  <brief_title>Incretin and CRTd.</brief_title>
  <official_title>Incretin Treatment Effect in Type 2 Diabetes Mellitus Patients Affected by Heart Failure With Depressed Ejection Fraction, and Treated by Cardiac Resynchronization Therapy With a Defibrillator.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In&#xD;
      this study the investigators will recruit T2DM patients affected by HF with depressed&#xD;
      ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will&#xD;
      randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients&#xD;
      investigators will report at follow up CRT-d responders rate, mortality, and hospital&#xD;
      admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s&#xD;
      conventional hypoglicemic drugs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>all cause mortality, and cardiac cause mortality.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital admissions for HF</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>incretin arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional hypoglycemic drug arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>T2DM with HF treated by CRTd participants will be assigned prospectively to placebo comparator (placebo plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Incretin Effect</intervention_name>
    <description>The patients will receive incretins therapy.</description>
    <arm_group_label>incretin arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization therapy defibrillator device</intervention_name>
    <description>The patients will receive a Cardiac Resynchronization therapy defibrillator device</description>
    <arm_group_label>conventional hypoglycemic drug arm</arm_group_label>
    <arm_group_label>incretin arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and&#xD;
             diagnosed failing heart with depressed ejection fraction; CRTd recipients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic&#xD;
             diseases; neoplastic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Raffaele Marfella</name>
      <address>
        <city>Naples</city>
        <zip>80128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Celestino Sardu</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Incretins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03282136
org study id: University of Campania
nct id: NCT03282136
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In
      this study the investigators will recruit T2DM patients affected by HF with depressed
      ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will
      randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients
      investigators will report at follow up CRT-d responders rate, mortality, and hospital
      admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s
      conventional hypoglicemic drugs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: all cause mortality, and cardiac cause mortality.
time frame: 12 months
measure: hospital admissions for HF
time frame: 12 months
arm group label: incretin arm
arm group type: Active Comparator
description: T2DM with HF treated by CRTd participants will be assigned prospectively to an intervention (incretin therapy plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
arm group label: conventional hypoglycemic drug arm
arm group type: Placebo Comparator
description: T2DM with HF treated by CRTd participants will be assigned prospectively to placebo comparator (placebo plus conventional hypoglycemic drug therapy) according to study protocol to evaluate the effect of the drug on cardiac deaths, all cause deaths, and hospital admission for heart failure.
intervention type: Drug
intervention name: Incretin Effect
description: The patients will receive incretins therapy.
arm group label: incretin arm
intervention type: Device
intervention name: Cardiac Resynchronization therapy defibrillator device
description: The patients will receive a Cardiac Resynchronization therapy defibrillator device
arm group label: conventional hypoglycemic drug arm
arm group label: incretin arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Celestino Sardu
investigator title: principal investigator
mesh term: Heart Failure
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Incretins
sharing ipd: Undecided