<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/NCT03830814</url>
  </required_header>
  <id_info>
    <org_study_id>YIG01201901</org_study_id>
    <nct_id>NCT03830814</nct_id>
  </id_info>
  <brief_title>The Effects of Sacubitril/Valsartan on the Heart Functions</brief_title>
  <official_title>What Are the Effects of Sacubitril/Valsartan on the Heart Functions? Can It Increase the Ejection Fraction?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Young Investigator Group of Cardiovascular Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Young Investigator Group of Cardiovascular Research</source>
  <oversight_info>
    <has_dmc>No</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>
      Background:&#xD;
&#xD;
      Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the&#xD;
      incidences of sudden cardiac death, death from worsening heart failure (HF), and&#xD;
      hospitalization. However, there is no prospective echocardiographic data describing the&#xD;
      effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse&#xD;
      remodeling. Therefore, the aim of our study was to evaluate the effects of&#xD;
      sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D)&#xD;
      echocardiography and the 3D strain parameters.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the&#xD;
      use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.&#xD;
      The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months&#xD;
      after starting the sacubitril/valsartan treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Two dimensional left ventricular ejection fraction</measure>
    <time_frame>3 months</time_frame>
    <description>Two dimensional ejection fraction is measured as baseline and after 3 months follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Three dimensional left ventricular ejection fraction</measure>
    <time_frame>3 months</time_frame>
    <description>Three dimensional ejection fraction is measured as baseline and after 3 months follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Two dimensional left ventricular volumes</measure>
    <time_frame>3 months</time_frame>
    <description>Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Three dimensional left ventricular volumes</measure>
    <time_frame>3 months</time_frame>
    <description>Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Drug Effect</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment</description>
    <arm_group_label>Cases</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred patients with heart failure with reduced ejection fraction (HRrEF) who have&#xD;
        indications for the use of sacubitril/valsartan as recommended by recent guidelines were&#xD;
        prospectively enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age is more than or equal 18 years old&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Indicated for the use of sacubitril/valsartan as recommended by the European Society&#xD;
             of Cardiology (ESC) heart failure guidelines 2016&#xD;
&#xD;
          -  Left ventricular ejection fraction of 40% or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior&#xD;
             to the start of this study or CRT implantation intentions&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Poor echocardiographic images&#xD;
&#xD;
          -  Sacubitril/valsartan treatment intolerance during the follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sacubitril/Valsartan</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Ejection Fraction</keyword>
  <!-- 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/NCT03830814
org study id: YIG01201901
nct id: NCT03830814
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background:

      Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the
      incidences of sudden cardiac death, death from worsening heart failure (HF), and
      hospitalization. However, there is no prospective echocardiographic data describing the
      effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse
      remodeling. Therefore, the aim of our study was to evaluate the effects of
      sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D)
      echocardiography and the 3D strain parameters.

      Methods:

      In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the
      use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.
      The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months
      after starting the sacubitril/valsartan treatment.
observational model: Case-Only
time perspective: Prospective
measure: Two dimensional left ventricular ejection fraction
time frame: 3 months
description: Two dimensional ejection fraction is measured as baseline and after 3 months follow-up
measure: Three dimensional left ventricular ejection fraction
time frame: 3 months
description: Three dimensional ejection fraction is measured as baseline and after 3 months follow-up
measure: Two dimensional left ventricular volumes
time frame: 3 months
description: Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up
measure: Three dimensional left ventricular volumes
time frame: 3 months
description: Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up
arm group label: Cases
description: Patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines
intervention type: Procedure
intervention name: Echocardiography
description: Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment
arm group label: Cases
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor