<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/NCT03287141</url>
  </required_header>
  <id_info>
    <org_study_id>1a2b3c4d</org_study_id>
    <nct_id>NCT03287141</nct_id>
  </id_info>
  <brief_title>CPAP Versus Bi-level in Chronic Heart Failure</brief_title>
  <acronym>CHF</acronym>
  <official_title>Comparison of CPAP and Bi-level Effects on Exercise Tolerance and Cardiorespiratory Responses in Individuals With Chronic Heart Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Patri-cia Angelica de Miranda Silva Nogueira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio Grande do Norte</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and&#xD;
      primarily responsible for exercise intolerance found in this syndrome. Now, It is known that&#xD;
      the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people&#xD;
      with heart failure; however, it's not yet known if the bi-level mode is able to generate&#xD;
      similar or even better results, due to pressure increase of the ventilatory support in this&#xD;
      modality. Moreover, it is possible that there is influence between the pressure levels set in&#xD;
      the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test&#xD;
      for differences between the acute effects of NIV on exercise tolerance in patients with HF,&#xD;
      when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of&#xD;
      Bi-level mode on the physical performance of these individuals, when applied at different&#xD;
      pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over&#xD;
      clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80&#xD;
      years, with chronic heart failure, functional class II and III (New York Heart Association)&#xD;
      in clinical stability. The experiment will be carried out on four different days, with a&#xD;
      48-hour interval between them, in which NIV will be used in the following modes: Bi-level&#xD;
      with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum&#xD;
      parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers&#xD;
      will participate in the four TGC. During the tests, distance walking, perceived levels of&#xD;
      fatigue and dyspnea, affective response, as well as other physiological variables will be&#xD;
      analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used,&#xD;
      followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as&#xD;
      statistically significant. Expected Results: This work is expected to improve the therapeutic&#xD;
      management of HF patients, assisting in the implementation and improvement of methods to&#xD;
      improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial, double-blind and cross-over, to be composed of&#xD;
      45 volunteers of both genders, aged between 30 and 80 years, with CHF will be selected from a&#xD;
      specialized outpatient clinic with medical consent. Patients should have symptoms of&#xD;
      compensated CHF; presenting functional capacity II and III (New York Heart Association), with&#xD;
      left ventricular ejection fraction &lt;50%; not participating in cardiac rehabilitation&#xD;
      programs; and clinical stability in the last three months, with no history of angina or&#xD;
      coexistence of obstructive pulmonary disease (Tiffeneau-Pinelli index&gt; 70% in spirometry). In&#xD;
      addition, they should not present any osteoarticular or neurological disease would prevents&#xD;
      them from performing the proposed tests, as well as having a score higher than 22 in the&#xD;
      Leganés cognitive test (20). In the case of NIV or exercise intolerance, as well as in case&#xD;
      of non-attendance to the experiments on the scheduled days, subjects will be excluded from&#xD;
      the study.&#xD;
&#xD;
      The sample will be the result of a non-probabilistic sampling process, calculated based on&#xD;
      the magnitude of the effect of the main variable (distance traveled) after the use of NIV&#xD;
      therapy, obtained in a pilot study. In addition, this protocol was aproved by the&#xD;
      institution's Ethics Committee on Human Research (CAAE: 49324415.0.000.5537).&#xD;
&#xD;
      Experimental procedure The experimental protocol will occur in three visits, one per day,&#xD;
      with a minimum interval of 48 hours between them. On the first visit, the volunteers will&#xD;
      undergo a screening that consists of clinical evaluation (assessment sheet) and cognitive&#xD;
      (Leganéscognitive test), as well as evaluation of lung function (spirometry) and QoL&#xD;
      (Minnesota Living with Heart Failure Questionnaire). Next, the Shuttlel Walking Test (SWT)&#xD;
      control (T-Co) will be performed, without previous use of NIV, in order to determine the&#xD;
      distance traveled and other physiological variables in the absence of interventions. Finally,&#xD;
      during the initial visit, a preliminary NIV session will be held to adjust the interface and&#xD;
      adapt the volunteer to the therapy.&#xD;
&#xD;
      At each subsequent visit, volunteers will perform a SWT immediately after 30 minutes of NIV,&#xD;
      one day in Bi-level mode and one in CPAP mode, following a randomized sequence. Thus, all&#xD;
      volunteers will perform one SWT after CPAP (T-CP) and one SWT after Bi-level (T-Bi). In the&#xD;
      experiment, the CPAP pressure will be maintained at 6 cmH2O, while at the Bi-level an&#xD;
      expiratory pressure (EPAP) of 6 cmH2O and an inspiratory pressure (IPAP) of 12 cmH2O will be&#xD;
      defined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 19, 2015</start_date>
  <completion_date type="Actual">March 23, 2016</completion_date>
  <primary_completion_date type="Actual">November 23, 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical exercise tolerance</measure>
    <time_frame>Immediately after the test</time_frame>
    <description>The distance covered in the shuttle walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of effort</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>The muscular fatigue of the legs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of dyspnea</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>The discomfort in the breath</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>The number of times an individual breathed in a minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>Heart rate reflecting heart beats for one minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>before and immediately after the test</time_frame>
    <description>Variable blood pressure analysis performed noninvasively.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>First intervention</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The subjects did a shuttle walk test without any previous intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Third intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shuttle walk test</intervention_name>
    <description>A shuttle walk test was performed without any previous intervention.</description>
    <arm_group_label>First intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive ventilation (Bi-pap)</intervention_name>
    <description>After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.</description>
    <arm_group_label>Third intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive ventilation (CPAP)</intervention_name>
    <description>After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.</description>
    <arm_group_label>Second intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Outpatient and have a compensated HF, without hospitalizations in the last three&#xD;
             months;&#xD;
&#xD;
          2. Present functional class II and III (New York Heart Association);&#xD;
&#xD;
          3. Present left ventricular ejection fraction (LVEF) ≤ 50%;&#xD;
&#xD;
          4. Have not suffered myocardial infarction in the last three months;&#xD;
&#xD;
          5. No previous diagnosis of chronic obstructive pulmonary disease (FEV1 / FVC ratio&gt; 70%&#xD;
             in spirometry);&#xD;
&#xD;
          6. Do not be a smoker;&#xD;
&#xD;
          7. Not being pregnant;&#xD;
&#xD;
          8. Does not present any clinical disease or restriction of osteomioarticular or&#xD;
             neurological origin that prevents / limits the carrying out of the proposed tests;&#xD;
&#xD;
          9. Integral cognitive functions, which were evaluated by the cognitive test of Leganés -&#xD;
             PCL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable angina or significant arrhythmias;&#xD;
&#xD;
          2. Acute atrial fibrillation or total atrioventricular block;&#xD;
&#xD;
          3. Systemic blood pressure (AP) at uncontrolled rest (≥ 180/110 mmHg or ≤80 / 40mmHg);&#xD;
&#xD;
          4. Resting heart rate (HR) ≤ 40 bpm or ≥ 120 bpm;&#xD;
&#xD;
          5. Need for dialysis;&#xD;
&#xD;
          6. Use of bronchodilator;&#xD;
&#xD;
          7. Respiratory rate (RF) at rest ≥ 35 rpm;&#xD;
&#xD;
          8. Frequent vomiting;&#xD;
&#xD;
          9. Intolerance to NIV;&#xD;
&#xD;
         10. infection or fever.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrícia Nogueira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>college professor</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 19, 2017</last_update_submitted>
  <last_update_submitted_qc>September 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio Grande do Norte</investigator_affiliation>
    <investigator_full_name>Patri-cia Angelica de Miranda Silva Nogueira</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>noninvasive ventilation</keyword>
  <keyword>continuous positive airway pressure</keyword>
  <keyword>intermittent positive-pressure breathing</keyword>
  <keyword>exercise test</keyword>
  <keyword>physical endurance</keyword>
  <keyword>physical fitness</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>Undecided</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/NCT03287141
org study id: 1a2b3c4d
nct id: NCT03287141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction: Dyspnea and fatigue are the main clinical symptoms of heart failure and
      primarily responsible for exercise intolerance found in this syndrome. Now, It is known that
      the use of NIV in CPAP mode applied before exercise increases exercise tolerance in people
      with heart failure; however, it's not yet known if the bi-level mode is able to generate
      similar or even better results, due to pressure increase of the ventilatory support in this
      modality. Moreover, it is possible that there is influence between the pressure levels set in
      the NIV and the magnitude of its effect on the exercise in this population Objective: 1) test
      for differences between the acute effects of NIV on exercise tolerance in patients with HF,
      when applied CPAP or bi-level mode; and 2) check for discrepancies in the acute effects of
      Bi-level mode on the physical performance of these individuals, when applied at different
      pressure levels. Methodology: This is a controlled, randomized, double-blind and cross-over
      clinical trial, to be composed of 45 volunteers of both genders, aged between 30 and 80
      years, with chronic heart failure, functional class II and III (New York Heart Association)
      in clinical stability. The experiment will be carried out on four different days, with a
      48-hour interval between them, in which NIV will be used in the following modes: Bi-level
      with minimum parameters (EPAP = 6 cmH2O and IPAP = 12 cmH2O), Bi-level with maximum
      parameters EPAP = 8 cmH2O and IPAP = 14 cmH2O) and CPAP (6 cmH2O). Thus, all the volunteers
      will participate in the four TGC. During the tests, distance walking, perceived levels of
      fatigue and dyspnea, affective response, as well as other physiological variables will be
      analyzed. Statistical analysis, the ANOVA test for repeated measurements will be used,
      followed by the Bonferroni post-test, considering p-value less than or equal to 0.05 as
      statistically significant. Expected Results: This work is expected to improve the therapeutic
      management of HF patients, assisting in the implementation and improvement of methods to
      improve dyspnea and muscle fatigue, thus increasing tolerance to exercise.
This study is a randomized controlled trial, double-blind and cross-over, to be composed of
      45 volunteers of both genders, aged between 30 and 80 years, with CHF will be selected from a
      specialized outpatient clinic with medical consent. Patients should have symptoms of
      compensated CHF; presenting functional capacity II and III (New York Heart Association), with
      left ventricular ejection fraction <50%; not participating in cardiac rehabilitation
      programs; and clinical stability in the last three months, with no history of angina or
      coexistence of obstructive pulmonary disease (Tiffeneau-Pinelli index> 70% in spirometry). In
      addition, they should not present any osteoarticular or neurological disease would prevents
      them from performing the proposed tests, as well as having a score higher than 22 in the
      Leganés cognitive test (20). In the case of NIV or exercise intolerance, as well as in case
      of non-attendance to the experiments on the scheduled days, subjects will be excluded from
      the study.

      The sample will be the result of a non-probabilistic sampling process, calculated based on
      the magnitude of the effect of the main variable (distance traveled) after the use of NIV
      therapy, obtained in a pilot study. In addition, this protocol was aproved by the
      institution's Ethics Committee on Human Research (CAAE: 49324415.0.000.5537).

      Experimental procedure The experimental protocol will occur in three visits, one per day,
      with a minimum interval of 48 hours between them. On the first visit, the volunteers will
      undergo a screening that consists of clinical evaluation (assessment sheet) and cognitive
      (Leganéscognitive test), as well as evaluation of lung function (spirometry) and QoL
      (Minnesota Living with Heart Failure Questionnaire). Next, the Shuttlel Walking Test (SWT)
      control (T-Co) will be performed, without previous use of NIV, in order to determine the
      distance traveled and other physiological variables in the absence of interventions. Finally,
      during the initial visit, a preliminary NIV session will be held to adjust the interface and
      adapt the volunteer to the therapy.

      At each subsequent visit, volunteers will perform a SWT immediately after 30 minutes of NIV,
      one day in Bi-level mode and one in CPAP mode, following a randomized sequence. Thus, all
      volunteers will perform one SWT after CPAP (T-CP) and one SWT after Bi-level (T-Bi). In the
      experiment, the CPAP pressure will be maintained at 6 cmH2O, while at the Bi-level an
      expiratory pressure (EPAP) of 6 cmH2O and an inspiratory pressure (IPAP) of 12 cmH2O will be
      defined.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Physical exercise tolerance
time frame: Immediately after the test
description: The distance covered in the shuttle walk test
measure: Perception of effort
time frame: before and immediately after the test
description: The muscular fatigue of the legs
measure: Perception of dyspnea
time frame: before and immediately after the test
description: The discomfort in the breath
measure: Respiratory rate
time frame: before and immediately after the test
description: The number of times an individual breathed in a minute.
measure: Peripheral oxygen saturation
time frame: before and immediately after the test
description: Noninvasive measurement of peripheral oxygen saturation by re-evaluating oxygenation rate.
measure: Heart rate
time frame: before and immediately after the test
description: Heart rate reflecting heart beats for one minute.
measure: Blood pressure
time frame: before and immediately after the test
description: Variable blood pressure analysis performed noninvasively.
arm group label: First intervention
arm group type: Sham Comparator
description: The subjects did a shuttle walk test without any previous intervention.
arm group label: Second intervention
arm group type: Experimental
description: Subjects underwent 30 minutes of noninvasive ventilation (CPAP) and then re-performed the shuttle walk test.
arm group label: Third intervention
arm group type: Experimental
description: Subjects underwent 30 minutes of noninvasive ventilation (Bi-pap) and then re-performed the shuttle walk test.
intervention type: Diagnostic Test
intervention name: Shuttle walk test
description: A shuttle walk test was performed without any previous intervention.
arm group label: First intervention
intervention type: Device
intervention name: Noninvasive ventilation (Bi-pap)
description: After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
arm group label: Third intervention
intervention type: Device
intervention name: Noninvasive ventilation (CPAP)
description: After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
arm group label: Second intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Patrícia Nogueira, PhD
role: Principal Investigator
affiliation: college professor
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade Federal do Rio Grande do Norte
investigator full name: Patri-cia Angelica de Miranda Silva Nogueira
investigator title: PhD
mesh term: Heart Failure
sharing ipd: Undecided