<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/NCT01707277</url>
  </required_header>
  <id_info>
    <org_study_id>EMI</org_study_id>
    <nct_id>NCT01707277</nct_id>
  </id_info>
  <brief_title>The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction</brief_title>
  <official_title>The Effects of Inspiratory Muscle Training in Patients With Heart Failure With Preserved Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have evaluated the effects of inspiratory muscle training in patiens with&#xD;
      heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic&#xD;
      role of inspiratory muscle training in patients with heart failure and preserved ejection&#xD;
      fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training&#xD;
      improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as&#xD;
      left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living&#xD;
      With Heart Failure Questionnaire) in patients with heart failure with preserved ejection&#xD;
      fraction and non-reduced inspiratory muscle strength.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in exercise capacity parameters at 12-weeks.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.&#xD;
Diastolic function: E/e´.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pharmacological treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <description>Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.</description>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual pahramacological treatment</description>
    <arm_group_label>Inspiratory muscle training</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a) previous history of symptomatic heart failure (New York Heart Association [NYHA]&#xD;
             functional class ≥II)&#xD;
&#xD;
          -  b) evidence of normal left ventricular ejection fraction, defined by an ejection&#xD;
             fraction &gt;0.50 and an end-diastolic diameter &lt;60 mm by 2D echocardiography&#xD;
&#xD;
          -  c) relevant structural heart disease (left ventricle hypertrophy/left atrial&#xD;
             enlargement) and/or diastolic dysfunction estimated by 2D echocardiography&#xD;
&#xD;
          -  d) clinical stability, including no admissions in the past 30 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a) Patients unable to perform a valid baseline exercise test.&#xD;
&#xD;
          -  b) Unstable angina, myocardial infarction or cardiac surgery within the previous three&#xD;
             months.&#xD;
&#xD;
          -  c)Known chronic metabolic, orthopedic, infectious disease or previous pulmonary&#xD;
             disease;&#xD;
&#xD;
          -  d)Treatment with steroids, hormones, or cancer chemotherapy;&#xD;
&#xD;
          -  e)Reduced maximal inspiratory pressure according to age and sex;&#xD;
&#xD;
          -  f)Active smokers&#xD;
&#xD;
          -  g)Acute decompensation;&#xD;
&#xD;
          -  h)Other comorbidity with an expectancy of life less than one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julio Núñez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clínico Universitario de Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Clínico Universitario</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36.</citation>
    <PMID>22993500</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>February 3, 2016</last_update_submitted>
  <last_update_submitted_qc>February 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Julio Nuñez</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Heart failure with preserved ejection fraction</keyword>
  <keyword>Inspiratory muscle training</keyword>
  <keyword>Exercise capacity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <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/NCT01707277
org study id: EMI
nct id: NCT01707277
lead sponsor: 
collaborator: 
has dmc: No
Previous studies have evaluated the effects of inspiratory muscle training in patiens with
      heart failure and reduced ejection fraction; nevertheless,no evidence endorse the therapeutic
      role of inspiratory muscle training in patients with heart failure and preserved ejection
      fraction. The investigators sought to evaluate whether 12-week inspiratory muscle training
      improves exercise capacity (peak exercise oxygen uptake and 6-minutes walk test), as well as
      left ventricular diastolic function, serum biomarkers and quality of life (Minnesota Living
      With Heart Failure Questionnaire) in patients with heart failure with preserved ejection
      fraction and non-reduced inspiratory muscle strength.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in exercise capacity parameters at 12-weeks.
time frame: 12 weeks
description: Exercise parameters: peak exercise oxygen uptake (peak VO2), 6-minutes walk test
measure: Changes in 12-week quality of life, biomarkers related to the severity and parameters of left ventricular diastolic function.
time frame: 12 weeks
description: Quality of life: Minnesota Living With Heart Failure Questionnaire. Biomarkers: plasma natriuretic peptides, estimaated glomerular filtration rate, antigen carbohydrate 125.
Diastolic function: E/e´.
arm group label: Inspiratory muscle training
arm group type: Experimental
description: Inspiratory muscle training for improving maximum inspiratory pressure plus phrmacological treatment Pharmacological treatment (usual care)
arm group label: Usual care
arm group type: Active Comparator
description: Pharmacological treatment
intervention type: Other
intervention name: Inspiratory muscle training
description: Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.
arm group label: Inspiratory muscle training
intervention type: Other
intervention name: Usual care
description: Usual pahramacological treatment
arm group label: Inspiratory muscle training
arm group label: Usual care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Julio Núñez, MD
role: Principal Investigator
affiliation: Hospital Clínico Universitario de Valencia
facility: 
country: Spain
citation: Lin SJ, McElfresh J, Hall B, Bloom R, Farrell K. Inspiratory muscle training in patients with heart failure: a systematic review. Cardiopulm Phys Ther J. 2012 Sep;23(3):29-36.
PMID: 22993500
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Julio Nuñez
investigator title: MD, PhD
mesh term: Respiratory Aspiration
mesh term: Heart Failure