<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/NCT03235843</url>
  </required_header>
  <id_info>
    <org_study_id>ISROTH20232</org_study_id>
    <nct_id>NCT03235843</nct_id>
  </id_info>
  <brief_title>Rate Adaptive Atrial Pacing in Heart Failure</brief_title>
  <acronym>ADAPTION</acronym>
  <official_title>Rate Adaptive Atrial Pacing in Heart Failure Patients With Chronotropic Incompetence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maasstad Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwest Clinics Alkmaar</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over&#xD;
      pilot study in a multi-center setting.&#xD;
&#xD;
      Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial&#xD;
      stimulation to restore functional capacity and quality of life in heart failure patients with&#xD;
      chronotropic incompetence.&#xD;
&#xD;
      Methods: heart failure patients (left ventricular ejection fraction ≤35% &amp; New York Heart&#xD;
      Assessment II or III) who were implanted with a 2-chamber implantable cardioverter&#xD;
      defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic&#xD;
      incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to&#xD;
      rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3&#xD;
      months the pacing mode will be switched to the opposite mode.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of quality of life</measure>
    <time_frame>3 months after changing the pacing mode</time_frame>
    <description>Measured with the Minnesota Living with Heart Failure Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of functional capacity</measure>
    <time_frame>3 months after changing the pacing mode</time_frame>
    <description>Measured with a six-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reversibility of chronotropic incompetence</measure>
    <time_frame>3 months after changing the pacing mode</time_frame>
    <description>A comparison of the modified HeartRateScore with and without rate adaptive pacing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical status</measure>
    <time_frame>3 months after changing the pacing mode</time_frame>
    <description>Measured with NYHA class assessment and number of hospitalizations for heart failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily activity level</measure>
    <time_frame>3 months after changing the pacing mode</time_frame>
    <description>Measured with the device's accelerometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Chronotropic Incompetence</condition>
  <condition>Heart Failure</condition>
  <condition>ICD</condition>
  <arm_group>
    <arm_group_label>Rate Adaptive Pacing ON</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AAIR pacing using a MV sensor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rate Adaptive Pacing OFF</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>DDI-pacing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AAIR pacing</intervention_name>
    <description>Rate adaptive pacing using a MV sensor.</description>
    <arm_group_label>Rate Adaptive Pacing ON</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DDI-pacing</intervention_name>
    <description>Rate adaptive pacing OFF</description>
    <arm_group_label>Rate Adaptive Pacing OFF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronotropic incompetence as assessed by a modified Heart Rate Score (mHRS)&#xD;
&#xD;
          2. Implanted with a Boston Scientific dual chamber ICD equipped with minute ventilation&#xD;
             sensor&#xD;
&#xD;
          3. Symptomatic congestive heart failure (NYHA class II-III)&#xD;
&#xD;
          4. Left ventricular systolic dysfunction (LVEF &lt;35%)&#xD;
&#xD;
          5. Optimal medical therapy&#xD;
&#xD;
          6. Sinus rhythm&#xD;
&#xD;
          7. Subjects should be able to perform normal daily activities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 or incapacitated adult&#xD;
&#xD;
          2. Documented atrial fibrillation in the last 3 months prior to inclusion&#xD;
&#xD;
          3. Indication for pacing (SSS, AV conduction abnormalities requiring pacing)&#xD;
&#xD;
          4. Respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator&#xD;
&#xD;
          5. Patients who are unable to tolerate increased pacing rates&#xD;
&#xD;
          6. Indication for cardiac resynchronization therapy&#xD;
&#xD;
        Beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion&#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>Cornelis P Allaart, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cornelis P Allaart, MD, PhD</last_name>
    <phone>+31 (0)20 4445043</phone>
    <email>cp.allaart@vumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne-Lotte CJ van der Lingen, MD</last_name>
    <phone>+31 (0)20 4443272</phone>
    <email>a.vanderlingen@vumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VU university medical center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Lotte van der Lingen, MD</last_name>
      <phone>+31204443272</phone>
      <email>a.vanderlingen@vumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.</citation>
    <PMID>21382903</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Cornelis P. Allaart</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Chronotropic Incompetence</keyword>
  <keyword>Rate Adaptive Pacing</keyword>
  <keyword>Minute Ventilation Sensor</keyword>
  <keyword>Primary Prevention ICD Therapy</keyword>
  <keyword>Implantable Cardioverter Defibrillator</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Exercise Intolerance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03235843
org study id: ISROTH20232
nct id: NCT03235843
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The ADAPTION trial is an investigator initiated prospective randomized doubleblind cross-over
      pilot study in a multi-center setting.

      Aim: to assess the ability of minute ventilation (MV) sensor driven rate adaptive atrial
      stimulation to restore functional capacity and quality of life in heart failure patients with
      chronotropic incompetence.

      Methods: heart failure patients (left ventricular ejection fraction ≤35% & New York Heart
      Assessment II or III) who were implanted with a 2-chamber implantable cardioverter
      defibrillator (ICD) device equipped with a MV sensor that are diagnosed with chronotropic
      incompetence will be included in the study. Patients will be randomized in a 1:1 fashion to
      rate responsive pacing (MV sensor only) function ON (AAIR mode) or OFF (DDI mode). After 3
      months the pacing mode will be switched to the opposite mode.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Patients enter a double blind randomized cross-over pilot study and will be randomized in a 1:1 fashion to either rate responsive (MV sensor only) function on or off. After 3 months the pacing mode will be switched to the opposite mode.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The pacing mode set by the pacemaker technician will not be disclosed to either patients or the study physician.
measure: Improvement of quality of life
time frame: 3 months after changing the pacing mode
description: Measured with the Minnesota Living with Heart Failure Questionnaire
measure: Improvement of functional capacity
time frame: 3 months after changing the pacing mode
description: Measured with a six-minute walk test
measure: Reversibility of chronotropic incompetence
time frame: 3 months after changing the pacing mode
description: A comparison of the modified HeartRateScore with and without rate adaptive pacing.
measure: Clinical status
time frame: 3 months after changing the pacing mode
description: Measured with NYHA class assessment and number of hospitalizations for heart failure.
measure: Daily activity level
time frame: 3 months after changing the pacing mode
description: Measured with the device's accelerometer
arm group label: Rate Adaptive Pacing ON
arm group type: Active Comparator
description: AAIR pacing using a MV sensor
arm group label: Rate Adaptive Pacing OFF
arm group type: Placebo Comparator
description: DDI-pacing
intervention type: Device
intervention name: AAIR pacing
description: Rate adaptive pacing using a MV sensor.
arm group label: Rate Adaptive Pacing ON
intervention type: Device
intervention name: DDI-pacing
description: Rate adaptive pacing OFF
arm group label: Rate Adaptive Pacing OFF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cornelis P Allaart, MD, PhD
role: Principal Investigator
affiliation: Amsterdam UMC, location VUmc
last name: Cornelis P Allaart, MD, PhD
phone: +31 (0)20 4445043
email: cp.allaart@vumc.nl
last name: Anne-Lotte CJ van der Lingen, MD
phone: +31 (0)20 4443272
email: a.vanderlingen@vumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
citation: Brubaker PH, Kitzman DW. Chronotropic incompetence: causes, consequences, and management. Circulation. 2011 Mar 8;123(9):1010-20. doi: 10.1161/CIRCULATIONAHA.110.940577. No abstract available.
PMID: 21382903
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Cornelis P. Allaart
investigator title: Principal Investigator
mesh term: Heart Failure
sharing ipd: No