<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/NCT04484298</url>
  </required_header>
  <id_info>
    <org_study_id>DYVIC2</org_study_id>
    <nct_id>NCT04484298</nct_id>
  </id_info>
  <brief_title>Dynamic Variation of Impedance Cardiography(DYVIC) as a Diagnostic Tool of Acute Heart Failure (AHF)</brief_title>
  <acronym>dyvic2</acronym>
  <official_title>Dynamic Variation of Impedance Cardiography (ICG) a Diagnostic Tool of Acute Heart Failure (AHF) in Emergency Department (ED) Patients Admitted for Acute Dyspnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Monastir</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Monastir</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 study aimed to evaluate the diagnostic performance of cardiac output (CO) change after&#xD;
      the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute heart failure (AHF) is a frequent condition in emergency department and is responsible&#xD;
      of high number of admissions, complications, and deaths.&#xD;
&#xD;
      despite advances in diagnostic techniques, AHF diagnosis still be challenging .&#xD;
&#xD;
      Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in&#xD;
      CO may be used to identify a change in the hemodynamic status of patient.&#xD;
&#xD;
      the gold standard of measuring CO is thermodilution catheterization, however it is an&#xD;
      invasive technique with high risks.&#xD;
&#xD;
      Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by&#xD;
      applying small electrical current to the chest through electrodes placed on the neck and&#xD;
      sides.&#xD;
&#xD;
      the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO&#xD;
      from the impedance waveform.&#xD;
&#xD;
      In practice, the investigators connect the device &quot;BIOPAC&quot; by using four electrodes which the&#xD;
      investigators place on the base of the neck (posterior face) and on the base of the thorax&#xD;
      (posterior face).&#xD;
&#xD;
      The ECG recording is taken simultaneously with two other electrodes placed at the right upper&#xD;
      limb and left lower limb.&#xD;
&#xD;
      In addition to detecting the electric current and the ECG, heart sounds are recorded using a&#xD;
      sensor that is placed at the mitral site.&#xD;
&#xD;
      Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO&#xD;
      is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO&#xD;
      measurement was repeated. CO is calculated by averaging three measurements at one minute&#xD;
      intervals at baseline and after NTG administration. DeltaCO was defined as the percent of&#xD;
      change of baseline CO after NTG test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups</measure>
    <time_frame>24 hours</time_frame>
    <description>the diagnostic performance is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>roc curve</measure>
    <time_frame>24</time_frame>
    <description>Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.</measure>
    <time_frame>24 hours</time_frame>
    <description>Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>reference group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations.&#xD;
FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TRINITRINE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.6 mg of nitroglycerin was given to the patient sublingual and we measure the cardiac output by BIOPAC system(0.6 mg of Nitroglycerin was administered sublingually and CO was evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Reference position patient is put in a 30 degree supine position during 5 minutes</intervention_name>
    <description>Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)</description>
    <arm_group_label>reference group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>nitroglucerin</intervention_name>
    <description>0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.</description>
    <arm_group_label>TRINITRINE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 year old or above non traumatic acute dyspnea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior&#xD;
             24 hours,&#xD;
&#xD;
          -  pericardial effusion ,&#xD;
&#xD;
          -  chest wall deformity suspected of causing dyspnea,&#xD;
&#xD;
          -  coma,&#xD;
&#xD;
          -  need for mechanical ventilation or vasopressor drugs,&#xD;
&#xD;
          -  serious and sustained arrhythmia,&#xD;
&#xD;
          -  pace maker,&#xD;
&#xD;
          -  severe mitral valve disease, severe pulmonary arterial hypertension,&#xD;
&#xD;
          -  renal failure (creatinine &gt;350µmol/l.&#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>nouira semir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Monastir</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency department of fattouma bourguiba university hospital</name>
      <address>
        <city>Monastir</city>
        <zip>5020</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Monastir</investigator_affiliation>
    <investigator_full_name>Pr. Semir Nouira</investigator_full_name>
    <investigator_title>professor semir nouira</investigator_title>
  </responsible_party>
  <keyword>dyspnea</keyword>
  <keyword>acute</keyword>
  <keyword>heart failure</keyword>
  <keyword>bio-impedance</keyword>
  <keyword>biopac system</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/NCT04484298
org study id: DYVIC2
nct id: NCT04484298
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the study aimed to evaluate the diagnostic performance of cardiac output (CO) change after
      the use of trinitrine in the diagnosis of heart failure patients with acute dyspnea.
Acute heart failure (AHF) is a frequent condition in emergency department and is responsible
      of high number of admissions, complications, and deaths.

      despite advances in diagnostic techniques, AHF diagnosis still be challenging .

      Measurement of cardiac output (CO) is used to evaluate global cardiac function and changes in
      CO may be used to identify a change in the hemodynamic status of patient.

      the gold standard of measuring CO is thermodilution catheterization, however it is an
      invasive technique with high risks.

      Impedance cardiography (ICG) is a noninvasive method for measuring CO. it is performed by
      applying small electrical current to the chest through electrodes placed on the neck and
      sides.

      the pulsatile flow of blood causes fluctuations in the current, and the device calculates CO
      from the impedance waveform.

      In practice, the investigators connect the device "BIOPAC" by using four electrodes which the
      investigators place on the base of the neck (posterior face) and on the base of the thorax
      (posterior face).

      The ECG recording is taken simultaneously with two other electrodes placed at the right upper
      limb and left lower limb.

      In addition to detecting the electric current and the ECG, heart sounds are recorded using a
      sensor that is placed at the mitral site.

      Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO
      is measured (baseline CO). NTG (0.6 mg) is then given to the patient sublingually and CO
      measurement was repeated. CO is calculated by averaging three measurements at one minute
      intervals at baseline and after NTG administration. DeltaCO was defined as the percent of
      change of baseline CO after NTG test.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Cardiac output variation measured by ICG before and after nitroglycerin in acute dyspneic patients between the AHF and non AHF groups
time frame: 24 hours
description: the diagnostic performance is evaluated by calculating the CO in ml/min by bio-impedance technique and compare the values between patients with and without AHF and between baseline.
measure: roc curve
time frame: 24
description: Receiver operating characteristic (ROC) curves for predicting HF were constructed and area under curve (AUC) was measured for the deltaCO.
measure: Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.
time frame: 24 hours
description: Sensitivity, specificity, positive and negative predictive values, and likelihood ratios of positive and negative results were calculated using the optimal cutoff value of deltaCO.
arm group label: reference group
arm group type: Experimental
description: patients presenting to the emergency department with acute onset dyspnea are assessed for acute heart failure using the bio impedance technology (BIOPAC system) to measure the cardiac output in different clinical situations.
FIRST: the cardiac output (CO) is measured at the reference position. Inbetween each step the patient was put in the reference position during 5 minutes.
arm group label: TRINITRINE
arm group type: Experimental
description: 0.6 mg of nitroglycerin was given to the patient sublingual and we measure the cardiac output by BIOPAC system(0.6 mg of Nitroglycerin was administered sublingually and CO was evaluated.
intervention type: Diagnostic Test
intervention name: Reference position patient is put in a 30 degree supine position during 5 minutes
description: Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)
arm group label: reference group
intervention type: Diagnostic Test
intervention name: nitroglucerin
description: 0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.
arm group label: TRINITRINE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: nouira semir, MD
role: Principal Investigator
affiliation: University of Monastir
facility: 
country: Tunisia
responsible party type: Principal Investigator
investigator affiliation: University of Monastir
investigator full name: Pr. Semir Nouira
investigator title: professor semir nouira
mesh term: Heart Failure
sharing ipd: No