<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/NCT03009552</url>
  </required_header>
  <id_info>
    <org_study_id>CAAE:59669416.0.0000.0068</org_study_id>
    <secondary_id>2015/10005-5</secondary_id>
    <nct_id>NCT03009552</nct_id>
  </id_info>
  <brief_title>Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure</brief_title>
  <acronym>STRAIN-DHF</acronym>
  <official_title>Speckle Tracking Echocardiography Adds Information in Decompensated Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marco Stephan Lofrano Alves</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the study is to determine whether speckle tracking echocardiography&#xD;
      presents additional prognostic value to the routine assessment (clinical and&#xD;
      echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the&#xD;
      emergency department. Specific objectives: 1 - To evaluate the association between changes in&#xD;
      the cardiac contractile mechanics (by serial measurements of strain, strain rate,&#xD;
      displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 -&#xD;
      Evaluate the possible association of these parameters with biomarkers of neurohormonal&#xD;
      activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and&#xD;
      cardiorenal syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ADHF syndromes comprise around one million of emergency admissions per year in the United&#xD;
      States, and the number of cases tripled in the last three decades, currently representing the&#xD;
      main cause of hospital admission in patients over the age of 65 years. A recent study showed&#xD;
      that among patients with similar risk in the presentation of ADHF, those admitted and treated&#xD;
      in the emergency (in attempt to get early discharge) have higher mortality rate than those&#xD;
      treated by hospitalization. On the other hand, uncertainty about the clinical course can also&#xD;
      result in prolonged and unnecessary hospitalizations, which burdens the health system and&#xD;
      consumes resources. Thus, It is vital to carry out studies that bring a better understanding&#xD;
      of the pathophysiology of ADHF and to determine new risk stratification tools in the&#xD;
      emergency department. Echocardiography is the most widely used imaging method and has a key&#xD;
      role in the diagnosis and management of patients with HF. However, some methodological&#xD;
      limitations of conventional echocardiography cause low reproducibility and intra and&#xD;
      inter-observer agreement for some parameters, reducing their prognostic ability. In recent&#xD;
      years, new technologies have been incorporated into the method in an attempt to overcome&#xD;
      these limitations. One of these new technologies is echocardiography with &quot;speckle tracking&quot;.&#xD;
      The method, by its nature, has a significant advantage over parameters derived from&#xD;
      conventional echocardiography, because of its ultrasound beam angle-independence. However,&#xD;
      there is a paucity of data on this new technology in patients with ADHF in literature and we&#xD;
      have not found studies evaluating the prognostic value of this method in a prospective cohort&#xD;
      of patients in this condition. This study aims to develop knowledge of this assessment tool&#xD;
      for cardiac mechanics in emergency care, exploring its potential prognostic value in patients&#xD;
      with ADHF, aiming to assist the cardiologist in identifying eligible patients for early and&#xD;
      safe discharge, and to identify those patients for whom hospitalization and longer treatment&#xD;
      are recommended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.</measure>
    <time_frame>Six months after admission</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)</measure>
    <time_frame>1 month after admission</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac mortality</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in left ventricle strain</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left ventricle strain rate</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left ventricle torsion</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left ventricle ejection fraction</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left atrial strain</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left atrial strain rate</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in left atrial volume</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle longitudinal strain</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle longitudinal strain rate</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle fractional area change</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle performance index</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle contraction-pressure index</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in right ventricle load adaptation index</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in tricuspid annular plane systolic excursion</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in tricuspid tissue Doppler peak systolic velocity (s´)</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in biventricular strain index</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum level of B-type natriuretic peptide (BNP)</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of troponin</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of galectin-3</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Serum levels of C-reactive protein</measure>
    <time_frame>72 hours after admission</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Decompensated Heart Failure</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>speckle tracking echocardiography</intervention_name>
    <description>Speckle tracking echocardiography is used for measuring parameters of cardiac mechanics: left ventricle strain and strain rate; left ventricle twist, untwist and torsion; left atrium strain and strain rate; right ventricle longitudinal strain and strain rate. Echocardiography will be performed within 24 hours of admission, 72 hours after admission and 1 month after discharge.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Decompensated heart failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission in the emergency for decompensated heart failure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systolic blood pressure &lt; 85, need surgical treatment, high ventricular frequency&#xD;
             atrial fibrillation or flutter, severe pulmonary disease, pulmonary embolism, septic&#xD;
             shock, advanced malignant neoplasia, pregnancy, heart transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Stephan L Alves, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Stephan L Alves, MD</last_name>
    <phone>+55 11 26615646</phone>
    <email>mslalves@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marco Stephan L Alves, MD</last_name>
    <phone>+55 11 26615646</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CEPEC - Centro de pesquisas em ecocardiografia e cardiologia</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Stephan L Alves, MD</last_name>
      <phone>+55 11 981431512</phone>
      <email>mslalves@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Wilson Mathias Jr, MD-PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cassio CS Machado, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Danilo B Moleta, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marco S Lofrano-Alves, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Marco Stephan Lofrano Alves</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>speckle tracking echocardiography</keyword>
  <keyword>strain</keyword>
  <keyword>strain rate</keyword>
  <keyword>torsion</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/NCT03009552
org study id: CAAE:59669416.0.0000.0068
secondary id: 2015/10005-5
nct id: NCT03009552
lead sponsor: 
has dmc: Yes
The overall objective of the study is to determine whether speckle tracking echocardiography
      presents additional prognostic value to the routine assessment (clinical and
      echocardiographic) in patients admitted with acute decompensated heart failure (ADHF) at the
      emergency department. Specific objectives: 1 - To evaluate the association between changes in
      the cardiac contractile mechanics (by serial measurements of strain, strain rate,
      displacement velocity, rotation and ventricular torsion) with clinical outcomes in ADHF. 2 -
      Evaluate the possible association of these parameters with biomarkers of neurohormonal
      activity, myocardial injury, fibrosis and myocardial remodeling, inflammatory activity, and
      cardiorenal syndrome.
ADHF syndromes comprise around one million of emergency admissions per year in the United
      States, and the number of cases tripled in the last three decades, currently representing the
      main cause of hospital admission in patients over the age of 65 years. A recent study showed
      that among patients with similar risk in the presentation of ADHF, those admitted and treated
      in the emergency (in attempt to get early discharge) have higher mortality rate than those
      treated by hospitalization. On the other hand, uncertainty about the clinical course can also
      result in prolonged and unnecessary hospitalizations, which burdens the health system and
      consumes resources. Thus, It is vital to carry out studies that bring a better understanding
      of the pathophysiology of ADHF and to determine new risk stratification tools in the
      emergency department. Echocardiography is the most widely used imaging method and has a key
      role in the diagnosis and management of patients with HF. However, some methodological
      limitations of conventional echocardiography cause low reproducibility and intra and
      inter-observer agreement for some parameters, reducing their prognostic ability. In recent
      years, new technologies have been incorporated into the method in an attempt to overcome
      these limitations. One of these new technologies is echocardiography with "speckle tracking".
      The method, by its nature, has a significant advantage over parameters derived from
      conventional echocardiography, because of its ultrasound beam angle-independence. However,
      there is a paucity of data on this new technology in patients with ADHF in literature and we
      have not found studies evaluating the prognostic value of this method in a prospective cohort
      of patients in this condition. This study aims to develop knowledge of this assessment tool
      for cardiac mechanics in emergency care, exploring its potential prognostic value in patients
      with ADHF, aiming to assist the cardiologist in identifying eligible patients for early and
      safe discharge, and to identify those patients for whom hospitalization and longer treatment
      are recommended.
observational model: Cohort
time perspective: Prospective
measure: Composite endpoint of mortality, heart transplant, left ventricular assist device and readmission for decompensated heart failure.
time frame: Six months after admission
measure: Development of cardio-renal syndrome (loss of more than 30% of calculated creatinine clearance or need for dialysis)
time frame: 1 month after admission
measure: Cardiac mortality
time frame: 6 months
measure: Changes in left ventricle strain
time frame: 72 hours after admission
measure: Changes in left ventricle strain rate
time frame: 72 hours after admission
measure: Changes in left ventricle torsion
time frame: 72 hours after admission
measure: Changes in left ventricle ejection fraction
time frame: 72 hours after admission
measure: Changes in left atrial strain
time frame: 72 hours after admission
measure: Changes in left atrial strain rate
time frame: 72 hours after admission
measure: Changes in left atrial volume
time frame: 72 hours after admission
measure: Changes in right ventricle longitudinal strain
time frame: 72 hours after admission
measure: Changes in right ventricle longitudinal strain rate
time frame: 72 hours after admission
measure: Changes in right ventricle fractional area change
time frame: 72 hours after admission
measure: Changes in right ventricle performance index
time frame: 72 hours after admission
measure: Changes in right ventricle contraction-pressure index
time frame: 72 hours after admission
measure: Changes in right ventricle load adaptation index
time frame: 72 hours after admission
measure: Changes in tricuspid annular plane systolic excursion
time frame: 72 hours after admission
measure: Changes in tricuspid tissue Doppler peak systolic velocity (s´)
time frame: 72 hours after admission
measure: Changes in biventricular strain index
time frame: 72 hours after admission
measure: Serum level of B-type natriuretic peptide (BNP)
time frame: 72 hours after admission
measure: Serum levels of troponin
time frame: 72 hours after admission
measure: Serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)
time frame: 72 hours after admission
measure: Serum levels of galectin-3
time frame: 72 hours after admission
measure: Serum levels of C-reactive protein
time frame: 72 hours after admission
intervention type: Procedure
intervention name: speckle tracking echocardiography
description: Speckle tracking echocardiography is used for measuring parameters of cardiac mechanics: left ventricle strain and strain rate; left ventricle twist, untwist and torsion; left atrium strain and strain rate; right ventricle longitudinal strain and strain rate. Echocardiography will be performed within 24 hours of admission, 72 hours after admission and 1 month after discharge.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marco Stephan L Alves, MD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Marco Stephan L Alves, MD
phone: +55 11 26615646
email: mslalves@hotmail.com
last name: Marco Stephan L Alves, MD
phone: +55 11 26615646
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Marco Stephan Lofrano Alves
investigator title: MD
mesh term: Heart Failure
sharing ipd: No