<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/NCT01671995</url>
  </required_header>
  <id_info>
    <org_study_id>OPTIMAL</org_study_id>
    <nct_id>NCT01671995</nct_id>
  </id_info>
  <brief_title>Optimising Congestive Heart Failure Outpatient Clinic Project</brief_title>
  <acronym>OPTIMAL</acronym>
  <official_title>Optimising Congestive Heart Failure Outpatient Clinic Project (OPTIMAL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines whether a nurse monitored management program at the hospital heart&#xD;
      failure outpatient clinic can improve quality of life in elderly patients with chronic heart&#xD;
      failure, as compared to standard treatment in primary healthcare.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients 60 years of age or more hospitalized with heart failure according to New York Heart&#xD;
      Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction&#xD;
      less than 0.45) are investigated before discharge and than randomized to the nurse monitored&#xD;
      management program or to standard care. Examinations are performed at 0, 6, 12, and 18&#xD;
      months, and include clinical signs and symptoms, quality of life, biochemical assessment,&#xD;
      echocardiography and drugs used. The study will be completed when all patients have passed&#xD;
      the 18 month follow up examination. Quality of life is assessed by the Nottingham health&#xD;
      profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 1996</start_date>
  <completion_date type="Actual">June 2001</completion_date>
  <primary_completion_date type="Actual">June 2001</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>Quality of life</measure>
    <time_frame>18 months</time_frame>
    <description>Nottingham health profile used for quality of life assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospitalizations</measure>
    <time_frame>18 months</time_frame>
    <description>Registry data that cover all hospitalizations for all patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of heart failure medication</measure>
    <time_frame>18 months</time_frame>
    <description>Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>18 months</time_frame>
    <description>Mortality from death certificates obtained.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Nurse monitored heart failure program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard primary health care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nurse monitored heart failure program</intervention_name>
    <description>Standard program for a heart failure clinic with information, education, drug titration</description>
    <arm_group_label>Nurse monitored heart failure program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard primary health care</intervention_name>
    <description>Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver</description>
    <arm_group_label>Standard primary health care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 60 years of age or older&#xD;
&#xD;
          -  Hospitalized with heart failure according to New York Heart Association (NYHA) class&#xD;
             II-IV&#xD;
&#xD;
          -  Left ventricular systolic dysfunction with an ejection fraction below 0.45, by&#xD;
             echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An acute myocardial infarction or unstable angina pectoris within the last three&#xD;
             months&#xD;
&#xD;
          -  Valvular stenosis&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Severe concomitant disease&#xD;
&#xD;
          -  Refusal to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magnus Edner, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danderyd University Hospital Corp</name>
      <address>
        <city>Stockholm</city>
        <zip>182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Mejhert M, Kahan T, Persson H, Edner M. Limited long term effects of a management programme for heart failure. Heart. 2004 Sep;90(9):1010-5. doi: 10.1136/hrt.2003.014407.</citation>
    <PMID>15310688</PMID>
  </results_reference>
  <results_reference>
    <citation>Mejhert M, Linder-Klingsell E, Edner M, Kahan T, Persson H. Ventilatory variables are strong prognostic markers in elderly patients with heart failure. Heart. 2002 Sep;88(3):239-43. doi: 10.1136/heart.88.3.239.</citation>
    <PMID>12181213</PMID>
  </results_reference>
  <results_reference>
    <citation>Mejhert M, Kahan T, Persson H, Edner M. Predicting readmissions and cardiovascular events in heart failure patients. Int J Cardiol. 2006 Apr 28;109(1):108-13. doi: 10.1016/j.ijcard.2005.07.015. Epub 2005 Oct 5.</citation>
    <PMID>16213040</PMID>
  </results_reference>
  <results_reference>
    <citation>Mejhert M, Kahan T, Edner M, Persson HE. Sex differences in systolic heart failure in the elderly: the prognostic importance of left ventricular mass in women. J Womens Health (Larchmt). 2008 Apr;17(3):373-81. doi: 10.1089/jwh.2007.0487.</citation>
    <PMID>18338962</PMID>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Thomas Kahan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Heart failure</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01671995
org study id: OPTIMAL
nct id: NCT01671995
lead sponsor: 
collaborator: 
has dmc: No
This study examines whether a nurse monitored management program at the hospital heart
      failure outpatient clinic can improve quality of life in elderly patients with chronic heart
      failure, as compared to standard treatment in primary healthcare.
Patients 60 years of age or more hospitalized with heart failure according to New York Heart
      Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction
      less than 0.45) are investigated before discharge and than randomized to the nurse monitored
      management program or to standard care. Examinations are performed at 0, 6, 12, and 18
      months, and include clinical signs and symptoms, quality of life, biochemical assessment,
      echocardiography and drugs used. The study will be completed when all patients have passed
      the 18 month follow up examination. Quality of life is assessed by the Nottingham health
      profile.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life
time frame: 18 months
description: Nottingham health profile used for quality of life assessment
measure: Hospitalizations
time frame: 18 months
description: Registry data that cover all hospitalizations for all patients
measure: Evaluation of heart failure medication
time frame: 18 months
description: Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication
measure: Mortality
time frame: 18 months
description: Mortality from death certificates obtained.
arm group label: Nurse monitored heart failure program
arm group type: Experimental
description: To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.
arm group label: Standard primary health care
arm group type: Active Comparator
description: To assess whether a nurse monitored management programme at the hospital outpatient clinic would improve quality of life, as compared to standard primary health care.
intervention type: Procedure
intervention name: Nurse monitored heart failure program
description: Standard program for a heart failure clinic with information, education, drug titration
arm group label: Nurse monitored heart failure program
intervention type: Procedure
intervention name: Standard primary health care
description: Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver
arm group label: Standard primary health care
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Magnus Edner, MD, PhD
role: Study Chair
affiliation: Karolinska Institutet
facility: 
country: Sweden
citation: Mejhert M, Kahan T, Persson H, Edner M. Limited long term effects of a management programme for heart failure. Heart. 2004 Sep;90(9):1010-5. doi: 10.1136/hrt.2003.014407.
PMID: 15310688
citation: Mejhert M, Linder-Klingsell E, Edner M, Kahan T, Persson H. Ventilatory variables are strong prognostic markers in elderly patients with heart failure. Heart. 2002 Sep;88(3):239-43. doi: 10.1136/heart.88.3.239.
PMID: 12181213
citation: Mejhert M, Kahan T, Persson H, Edner M. Predicting readmissions and cardiovascular events in heart failure patients. Int J Cardiol. 2006 Apr 28;109(1):108-13. doi: 10.1016/j.ijcard.2005.07.015. Epub 2005 Oct 5.
PMID: 16213040
citation: Mejhert M, Kahan T, Edner M, Persson HE. Sex differences in systolic heart failure in the elderly: the prognostic importance of left ventricular mass in women. J Womens Health (Larchmt). 2008 Apr;17(3):373-81. doi: 10.1089/jwh.2007.0487.
PMID: 18338962
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Thomas Kahan
investigator title: Professor
mesh term: Heart Failure