<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/NCT03803826</url>
  </required_header>
  <id_info>
    <org_study_id>FNO-STRAINS</org_study_id>
    <nct_id>NCT03803826</nct_id>
  </id_info>
  <brief_title>Cardiac Strains for Optimization of CRT in Non-Responders</brief_title>
  <official_title>Use of Cardiac Strains for Optimization of Cardiac Resynchronization Therapy in Non-Responders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</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 study is to investigate the possibility of optimizing the performance of&#xD;
      CRT-D in non-responding patients through utilization of cardiac strain speckle tracking&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to&#xD;
      any improvement of the patients' status.&#xD;
&#xD;
      In this study, an investigation of a possible method of optimization through speckle tracking&#xD;
      of cardiac strains is attempted.&#xD;
&#xD;
      Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3&#xD;
      months are randomly divided into control and intervention groups. Atrioventricular interval&#xD;
      is adjusted so that E and A waves do not overlap and the interventricular interval&#xD;
      subsequently optimized to yield maximum improvement of the sum of&#xD;
      longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF)&#xD;
      and NYHA (New York Heart Association Classification improvement 3 months after optimization&#xD;
      are evaluated and use of other strain combinations assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and the use of other strain combinations assessed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the left ventricular ejection fraction</measure>
    <time_frame>6 months from CRT-D implantation, 3 months from optimization</time_frame>
    <description>Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA Classification</measure>
    <time_frame>6 months from CRT-D implantation, 3 months from optimization</time_frame>
    <description>NYHA (New York Heart Association Classification measured using the standard NYHA range I to IV - I being the best result, IV the worst) was evaluated using a standard NYHA questionnaire before optimization and 3 months after optimization during a follow-up examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chronic Heart Failure</condition>
  <arm_group>
    <arm_group_label>CRT-D re-programming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography to:&#xD;
adjust the atrioventricular interval so that E and A waves do not overlap&#xD;
the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.&#xD;
Transthoracic echocardiography is performed prior to optimization and 3 months after optimization (i.e., 3 and 6 months after the CRT implantation) and and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods re-programming of the interventricular interval</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only trans-thoracic echocardiography is performed during follow-ups at 3 and 6 months from CRT implantations performed and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRT-D re-programming</intervention_name>
    <description>The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:&#xD;
adjust the atrioventricular interval so that E and A waves do not overlap&#xD;
the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.</description>
    <arm_group_label>CRT-D re-programming</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Trans-Thoracic Echocardiography</intervention_name>
    <description>This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D&#xD;
Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.</description>
    <arm_group_label>CRT-D re-programming</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment&#xD;
             options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to&#xD;
             the implantation of CRT-D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18&#xD;
&#xD;
          -  response to the original CRT implantation&#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>David Sipula, MUDr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava, Dpt of Cardiovascular Diseases</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>70800</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac resynchronization therapy</keyword>
  <keyword>non-responders</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/NCT03803826
org study id: FNO-STRAINS
nct id: NCT03803826
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the possibility of optimizing the performance of
      CRT-D in non-responding patients through utilization of cardiac strain speckle tracking
In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to
      any improvement of the patients' status.

      In this study, an investigation of a possible method of optimization through speckle tracking
      of cardiac strains is attempted.

      Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3
      months are randomly divided into control and intervention groups. Atrioventricular interval
      is adjusted so that E and A waves do not overlap and the interventricular interval
      subsequently optimized to yield maximum improvement of the sum of
      longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF)
      and NYHA (New York Heart Association Classification improvement 3 months after optimization
      are evaluated and use of other strain combinations assessed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months from implementation are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap, the interventricular interval iss subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and the use of other strain combinations assessed.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the left ventricular ejection fraction
time frame: 6 months from CRT-D implantation, 3 months from optimization
description: Left ventricular ejection fraction measured by transthoracic echocardiography prior to optimizing and during a follow-up examination three month after optimizing
measure: Change in NYHA Classification
time frame: 6 months from CRT-D implantation, 3 months from optimization
description: NYHA (New York Heart Association Classification measured using the standard NYHA range I to IV - I being the best result, IV the worst) was evaluated using a standard NYHA questionnaire before optimization and 3 months after optimization during a follow-up examination
arm group label: CRT-D re-programming
arm group type: Experimental
description: The ineffective previously implanted CRT-D is reprogrammed under supervision of transthoracic echocardiography to:
adjust the atrioventricular interval so that E and A waves do not overlap
the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
Transthoracic echocardiography is performed prior to optimization and 3 months after optimization (i.e., 3 and 6 months after the CRT implantation) and and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods re-programming of the interventricular interval
arm group label: Control Group
arm group type: No Intervention
description: Only trans-thoracic echocardiography is performed during follow-ups at 3 and 6 months from CRT implantations performed and New York Heart Association Classification (NYHA Classification; total score range 1-4) is being determined in accordance with the standard NYHA methods
intervention type: Device
intervention name: CRT-D re-programming
description: The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:
adjust the atrioventricular interval so that E and A waves do not overlap
the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains.
arm group label: CRT-D re-programming
intervention type: Diagnostic Test
intervention name: Trans-Thoracic Echocardiography
description: This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D
Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing.
arm group label: CRT-D re-programming
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Sipula, MUDr.
role: Principal Investigator
affiliation: University Hospital Ostrava, Dpt of Cardiovascular Diseases
facility: 
country: Czechia
responsible party type: Sponsor
mesh term: Heart Failure