<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/NCT04425785</url>
  </required_header>
  <id_info>
    <org_study_id>2-115-18</org_study_id>
    <nct_id>NCT04425785</nct_id>
  </id_info>
  <brief_title>Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study</brief_title>
  <acronym>PLEASE</acronym>
  <official_title>Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aberdeen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</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>
      Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense&#xD;
      emotional or physical stress. Recovery of this condition varies and many patients continue to&#xD;
      suffer from symptoms such as fatigue and breathlessness for a protracted period after their&#xD;
      event. Research conducted in our unit has found that the heart function does not recover&#xD;
      fully as is commonly believed and that the energetic status of the heart remains impaired for&#xD;
      an extended period of time. The purpose of our study is to establish whether following a&#xD;
      structured exercise program or a mental wellbeing program compared to usual care for 12 weeks&#xD;
      after an episode of Takotsubo will improve the energy status of the heart, their physical&#xD;
      conditioning and improve the general mental wellbeing of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction&#xD;
      precipitated by major stress. The researchers have shown that recovery is more protracted&#xD;
      than previously appreciated, and is associated with persistent major morbidity and a&#xD;
      long-term heart failure phenotype. In the absence of any effective therapeutic options, the&#xD;
      researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation&#xD;
      (standardised physical exercise training or cognitive behavioural therapy) versus current&#xD;
      standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.&#xD;
      The primary end-point will be the restoration of cardiac energetic status assessed by&#xD;
      31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening&#xD;
      response, global longitudinal strain by echocardiography and the 6-minute walk test. If&#xD;
      successful, this has the potential for rapid implementation into a large randomised clinical&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>Randomised controlled study. Takotsubo patients will be randomised into one of the following groups:&#xD;
Exercise Arm Cognitive Behavioural Arm Standard Clinical Care</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac Energetics</measure>
    <time_frame>Within three weeks after diagnosis</time_frame>
    <description>Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiac Energetics</measure>
    <time_frame>At completion of 12 weeks intervention</time_frame>
    <description>Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Global Longitudinal Strain</measure>
    <time_frame>Within three weeks after diagnosis</time_frame>
    <description>Echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Global Longitudinal Strain</measure>
    <time_frame>At completion of 12 weeks intervention</time_frame>
    <description>Echocardiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity</measure>
    <time_frame>Within three weeks after diagnosis</time_frame>
    <description>6 minute walk test and Cardiopulmonary Exercise Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise Capacity</measure>
    <time_frame>At completion of 12 weeks intervention</time_frame>
    <description>6 minute walk test and Cardiopulmonary Exercise Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental status and Stress</measure>
    <time_frame>Within three weeks after diagnosis</time_frame>
    <description>Index of Mental Wellbeing and Cortisol Awakening Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental status and Stress</measure>
    <time_frame>At completion of 12 weeks intervention</time_frame>
    <description>Index of Mental Wellbeing and Cortisol Awakening Response</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Takotsubo Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>Physical Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A structured exercise program for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioural Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Behavioural Therapy for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Clinical Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard Clinical Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Exercise Program</intervention_name>
    <description>A structured exercise program</description>
    <arm_group_label>Physical Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioural Therapy</intervention_name>
    <description>A structured cognitive behavioural therapy program</description>
    <arm_group_label>Cognitive Behavioural Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A patient who has recently suffered an episode of takotsubo cardiomyopathy within the&#xD;
             last three weeks&#xD;
&#xD;
          -  Participant who is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that&#xD;
             would preclude them for taking part in a physical exercise training program.&#xD;
&#xD;
          -  Any patient who is not able or not willing to travel to the cardiovascular research&#xD;
             facility for their study visits.&#xD;
&#xD;
          -  Any patient who is not able to commit to a 12 week supervised training program.&#xD;
&#xD;
          -  Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic&#xD;
             limbs).&#xD;
&#xD;
          -  Contraindication to magnetic resonance scanning such as an implantable cardiac device.&#xD;
&#xD;
          -  Pregnancy&#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>Dana Dawson, MPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Gamble</last_name>
    <phone>01224559573</phone>
    <email>david.gamble@abdn.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amelia E Rudd, BSc</last_name>
    <phone>01224559573</phone>
    <phone_ext>01467642401</phone_ext>
    <email>a.e.rudd@abdn.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cardiac Research Facility</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeenshire</state>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amelia Rudd, BSc</last_name>
      <phone>01224559573</phone>
      <phone_ext>01467642401</phone_ext>
      <email>a.e.rudd@abdn.ac.uk</email>
    </contact>
    <contact_backup>
      <last_name>David Gamble</last_name>
      <phone>01224559573</phone>
      <email>david.gamble@abdn.ac.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
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  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Takotsubo Cardiomyopathy</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/NCT04425785
org study id: 2-115-18
nct id: NCT04425785
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense
      emotional or physical stress. Recovery of this condition varies and many patients continue to
      suffer from symptoms such as fatigue and breathlessness for a protracted period after their
      event. Research conducted in our unit has found that the heart function does not recover
      fully as is commonly believed and that the energetic status of the heart remains impaired for
      an extended period of time. The purpose of our study is to establish whether following a
      structured exercise program or a mental wellbeing program compared to usual care for 12 weeks
      after an episode of Takotsubo will improve the energy status of the heart, their physical
      conditioning and improve the general mental wellbeing of patients.
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction
      precipitated by major stress. The researchers have shown that recovery is more protracted
      than previously appreciated, and is associated with persistent major morbidity and a
      long-term heart failure phenotype. In the absence of any effective therapeutic options, the
      researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation
      (standardised physical exercise training or cognitive behavioural therapy) versus current
      standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.
      The primary end-point will be the restoration of cardiac energetic status assessed by
      31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening
      response, global longitudinal strain by echocardiography and the 6-minute walk test. If
      successful, this has the potential for rapid implementation into a large randomised clinical
      trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised controlled study. Takotsubo patients will be randomised into one of the following groups:
Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
primary purpose: Basic Science
masking: None (Open Label)
measure: Cardiac Energetics
time frame: Within three weeks after diagnosis
description: Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
measure: Cardiac Energetics
time frame: At completion of 12 weeks intervention
description: Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
measure: Left Ventricular Global Longitudinal Strain
time frame: Within three weeks after diagnosis
description: Echocardiography
measure: Left Ventricular Global Longitudinal Strain
time frame: At completion of 12 weeks intervention
description: Echocardiography
measure: Exercise Capacity
time frame: Within three weeks after diagnosis
description: 6 minute walk test and Cardiopulmonary Exercise Test
measure: Exercise Capacity
time frame: At completion of 12 weeks intervention
description: 6 minute walk test and Cardiopulmonary Exercise Test
measure: Mental status and Stress
time frame: Within three weeks after diagnosis
description: Index of Mental Wellbeing and Cortisol Awakening Response
measure: Mental status and Stress
time frame: At completion of 12 weeks intervention
description: Index of Mental Wellbeing and Cortisol Awakening Response
arm group label: Physical Exercise Group
arm group type: Experimental
description: A structured exercise program for 12 weeks
arm group label: Cognitive Behavioural Therapy
arm group type: Experimental
description: Cognitive Behavioural Therapy for 12 weeks
arm group label: Standard Clinical Care
arm group type: No Intervention
description: Standard Clinical Care
intervention type: Other
intervention name: Physical Exercise Program
description: A structured exercise program
arm group label: Physical Exercise Group
intervention type: Behavioral
intervention name: Cognitive Behavioural Therapy
description: A structured cognitive behavioural therapy program
arm group label: Cognitive Behavioural Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dana Dawson, MPhil
role: Principal Investigator
affiliation: University of Aberdeen
last name: David Gamble
phone: 01224559573
email: david.gamble@abdn.ac.uk
last name: Amelia E Rudd, BSc
phone: 01224559573
phone ext: 01467642401
email: a.e.rudd@abdn.ac.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
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PMID: 28599831
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Takotsubo Cardiomyopathy
sharing ipd: No