<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/NCT04461392</url>
  </required_header>
  <id_info>
    <org_study_id>BC032020_1</org_study_id>
    <nct_id>NCT04461392</nct_id>
  </id_info>
  <brief_title>Exercise Response After Revalidation in Cancer Patients</brief_title>
  <official_title>Role of Myocardial Work in the Prediction of Cardiac Dysfunction and Response After Revalidation in Patients With Cancer Undergoing Chemotherapy and/or Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</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>
      This study regarding oncological patients for rehabilitation after specific cancer therapy&#xD;
      involves three aims: (1) to evaluate the predictive value of myocardial work parameters on&#xD;
      the improvement of exercise performance after rehabilitation, (2) to determine which&#xD;
      echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to&#xD;
      evaluate the correlation between echocardiographic parameters and fibrosis detected by&#xD;
      cardiac magnetic resonance imaging (CMR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Myocardial work (MW) provides an estimation of cardiac function by combining global&#xD;
      longitudinal strain (GLS) with blood pressure values obtained non-invasively, being less load&#xD;
      dependent than standard GLS. The investigator hypothesize that myocardial work could be a&#xD;
      useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy&#xD;
      in oncological patients undergoing rehabilitation. Moreover, this study may provide&#xD;
      additional information in optimal selection for rehabilitation programs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in peak volume oxygen - VO2 (L/min)</measure>
    <time_frame>change from baseline (before rehabilitation) at 15 months (after rehabilitation)</time_frame>
    <description>represents the maximum oxygen consumption during incremental exercise that is measured during Cardiopulmonary Exercise test (CPET), being a measure of aerobic capacity of the subject</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope</measure>
    <time_frame>change from baseline (before rehabilitation) at 15 months (after rehabilitation)</time_frame>
    <description>this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the respiratory exchange ratio (RER)</measure>
    <time_frame>change from baseline (before rehabilitation) at 15 months (after rehabilitation)</time_frame>
    <description>represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in myocardial work (MW)</measure>
    <time_frame>change from baseline (before rehabilitation) at 15 months (after rehabilitation)</time_frame>
    <description>Myocardial work (MW) is a non-invasive, less load-dependent echocardiographic parameter obtained during standard transthoracic echography using the pressure-strain loop data.&#xD;
This parameter consists of the following measurements: Global constructive work (GCW) Global wasted work (GWW), Global work index (GWI), and Global work efficiency (GWE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health status</measure>
    <time_frame>change from baseline (before rehabilitation) at 15 months (after rehabilitation)</time_frame>
    <description>Self-assessment of the generic health status using the EQ-5D-5L questionnaire. This questionnaire assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, on a five-level scale.&#xD;
In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS) from 0 ('the worst health you can imagine') - 100 ('the best health you can imagine')</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiovascular events (MACE)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">191</enrollment>
  <condition>Oncology</condition>
  <condition>Cardiac Toxicity</condition>
  <arm_group>
    <arm_group_label>Oncology patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Cardiorespiratory exercise test</intervention_name>
    <description>Cardiorespiratory exercise test to evaluate the exercise tolerance&#xD;
Cardiac imaging for the assessment of the left atrium anatomy and function.</description>
    <arm_group_label>Oncology patients</arm_group_label>
    <other_name>cardiac computed tomography</other_name>
    <other_name>cardiac magnetic resonance</other_name>
    <other_name>echocardiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with cancer&#xD;
&#xD;
          2. Undergoing chemotherapy and/or radiotherapy/hormone therapy&#xD;
&#xD;
          3. Age older than 18 years old - maximum age of 90 years old&#xD;
&#xD;
          4. Willing to enter revalidation in Universitair Ziekenhuis Brussel&#xD;
&#xD;
          5. Signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe aortic stenosis defined as aortic valve aria under 0.6 cm2/m2&#xD;
&#xD;
          2. Supraventricular arrhythmias&#xD;
&#xD;
          3. Poor image quality for 2D and 3D echocardiography defined as the impossibility to&#xD;
             examine of more than 2 adjacent segments&#xD;
&#xD;
          4. Resistant hypertension defined as uncontrolled blood pressure values under current&#xD;
             European guidelines, Systolic Blood Pressure more than 140 mmHg and/or Diastolic Blood&#xD;
             Pressure more than 80 mmHg&#xD;
&#xD;
          5. Lung cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard Cosyns, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Steven Droogmans, Professor</last_name>
    <phone>024776009</phone>
    <email>steven.droogmans@uzbrussel.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Steven Droogmans, PhD</last_name>
      <phone>024776009</phone>
      <email>steven.droogmans@uzbrussel.be</email>
    </contact>
    <contact_backup>
      <last_name>Luiza Luchian</last_name>
      <phone>024776009</phone>
      <email>marialuiza.luchian@uzbrussel.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available. Erratum In: Eur Heart J. 2016 Dec 24;:</citation>
    <PMID>27567406</PMID>
  </reference>
  <reference>
    <citation>Ferreira de Souza T, Quinaglia A C Silva T, Osorio Costa F, Shah R, Neilan TG, Velloso L, Nadruz W, Brenelli F, Sposito AC, Matos-Souza JR, Cendes F, Coelho OR, Jerosch-Herold M, Coelho-Filho OR. Anthracycline Therapy Is Associated With Cardiomyocyte Atrophy and Preclinical Manifestations of Heart Disease. JACC Cardiovasc Imaging. 2018 Aug;11(8):1045-1055. doi: 10.1016/j.jcmg.2018.05.012.</citation>
    <PMID>30092965</PMID>
  </reference>
  <reference>
    <citation>Piepoli MF, Abreu A, Albus C, Ambrosetti M, Brotons C, Catapano AL, Corra U, Cosyns B, Deaton C, Graham I, Hoes A, Lochen ML, Matrone B, Redon J, Sattar N, Smulders Y, Tiberi M. Update on cardiovascular prevention in clinical practice: A position paper of the European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2020 Jan;27(2):181-205. doi: 10.1177/2047487319893035. Epub 2019 Dec 12.</citation>
    <PMID>31826679</PMID>
  </reference>
  <reference>
    <citation>Kosmas CE, Silverio D, Sourlas A, Montan PD, Guzman E. Role of spironolactone in the treatment of heart failure with preserved ejection fraction. Ann Transl Med. 2018 Dec;6(23):461. doi: 10.21037/atm.2018.11.16.</citation>
    <PMID>30603649</PMID>
  </reference>
  <reference>
    <citation>Schrub F, Schnell F, Donal E, Galli E. Myocardial work is a predictor of exercise tolerance in patients with dilated cardiomyopathy and left ventricular dyssynchrony. Int J Cardiovasc Imaging. 2020 Jan;36(1):45-53. doi: 10.1007/s10554-019-01689-4. Epub 2019 Sep 12.</citation>
    <PMID>31515694</PMID>
  </reference>
  <reference>
    <citation>Galli E, Vitel E, Schnell F, Le Rolle V, Hubert A, Lederlin M, Donal E. Myocardial constructive work is impaired in hypertrophic cardiomyopathy and predicts left ventricular fibrosis. Echocardiography. 2019 Jan;36(1):74-82. doi: 10.1111/echo.14210. Epub 2018 Nov 29.</citation>
    <PMID>30488501</PMID>
  </reference>
  <reference>
    <citation>Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:</citation>
    <PMID>27206819</PMID>
  </reference>
  <reference>
    <citation>Moneghetti KJ, Kobayashi Y, Christle JW, Ariyama M, Vrtovec B, Kouznetsova T, Wilson A, Ashley E, Wheeler MT, Myers J, Haddad F. Contractile reserve and cardiopulmonary exercise parameters in patients with dilated cardiomyopathy, the two dimensions of exercise testing. Echocardiography. 2017 Aug;34(8):1179-1186. doi: 10.1111/echo.13623. Epub 2017 Jul 6.</citation>
    <PMID>28681553</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Bernard Cosyns</investigator_full_name>
    <investigator_title>Head of Department</investigator_title>
  </responsible_party>
  <keyword>Echocardiography</keyword>
  <keyword>Revalidation</keyword>
  <keyword>Cardiovascular magnetic resonance imaging</keyword>
  <keyword>Oncology</keyword>
  <keyword>Radiotherapy</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Cardiorespiratory exercise test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</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/NCT04461392
org study id: BC032020_1
nct id: NCT04461392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study regarding oncological patients for rehabilitation after specific cancer therapy
      involves three aims: (1) to evaluate the predictive value of myocardial work parameters on
      the improvement of exercise performance after rehabilitation, (2) to determine which
      echocardiographic parameters are more suitable in predicting cardiac dysfunction, and (3) to
      evaluate the correlation between echocardiographic parameters and fibrosis detected by
      cardiac magnetic resonance imaging (CMR).
Myocardial work (MW) provides an estimation of cardiac function by combining global
      longitudinal strain (GLS) with blood pressure values obtained non-invasively, being less load
      dependent than standard GLS. The investigator hypothesize that myocardial work could be a
      useful marker for predicting the exercise performance after chemotherapy and/or radiotherapy
      in oncological patients undergoing rehabilitation. Moreover, this study may provide
      additional information in optimal selection for rehabilitation programs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Change in peak volume oxygen - VO2 (L/min)
time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
description: represents the maximum oxygen consumption during incremental exercise that is measured during Cardiopulmonary Exercise test (CPET), being a measure of aerobic capacity of the subject
measure: Change in the minute ventilation/carbon dioxide production (VE/VCO2) slope
time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
description: this parameter shows the increase in ventilation in response to CO2 production, thus it measures the ventilatory efficiency
measure: Change in the respiratory exchange ratio (RER)
time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
description: represents the ratio between exhaled CO2 and inhale O2 may quantify the grade of the effort
measure: Change in myocardial work (MW)
time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
description: Myocardial work (MW) is a non-invasive, less load-dependent echocardiographic parameter obtained during standard transthoracic echography using the pressure-strain loop data.
This parameter consists of the following measurements: Global constructive work (GCW) Global wasted work (GWW), Global work index (GWI), and Global work efficiency (GWE)
measure: Change in health status
time frame: change from baseline (before rehabilitation) at 15 months (after rehabilitation)
description: Self-assessment of the generic health status using the EQ-5D-5L questionnaire. This questionnaire assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, on a five-level scale.
In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS) from 0 ('the worst health you can imagine') - 100 ('the best health you can imagine')
measure: Major adverse cardiovascular events (MACE)
time frame: through study completion, an average of 1 year
description: nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
arm group label: Oncology patients
arm group type: Experimental
description: Patients diagnosed with cancer and treated with chemotherapy and/or radiotherapy
intervention type: Diagnostic Test
intervention name: Cardiorespiratory exercise test
description: Cardiorespiratory exercise test to evaluate the exercise tolerance
Cardiac imaging for the assessment of the left atrium anatomy and function.
arm group label: Oncology patients
other name: cardiac computed tomography
other name: cardiac magnetic resonance
other name: echocardiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Bernard Cosyns, Professor
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
last name: Steven Droogmans, Professor
phone: 024776009
email: steven.droogmans@uzbrussel.be
facility: 
contact: 
contact backup: 
country: Belgium
citation: Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available. Erratum In: Eur Heart J. 2016 Dec 24;:
PMID: 27567406
citation: Ferreira de Souza T, Quinaglia A C Silva T, Osorio Costa F, Shah R, Neilan TG, Velloso L, Nadruz W, Brenelli F, Sposito AC, Matos-Souza JR, Cendes F, Coelho OR, Jerosch-Herold M, Coelho-Filho OR. Anthracycline Therapy Is Associated With Cardiomyocyte Atrophy and Preclinical Manifestations of Heart Disease. JACC Cardiovasc Imaging. 2018 Aug;11(8):1045-1055. doi: 10.1016/j.jcmg.2018.05.012.
PMID: 30092965
citation: Piepoli MF, Abreu A, Albus C, Ambrosetti M, Brotons C, Catapano AL, Corra U, Cosyns B, Deaton C, Graham I, Hoes A, Lochen ML, Matrone B, Redon J, Sattar N, Smulders Y, Tiberi M. Update on cardiovascular prevention in clinical practice: A position paper of the European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2020 Jan;27(2):181-205. doi: 10.1177/2047487319893035. Epub 2019 Dec 12.
PMID: 31826679
citation: Kosmas CE, Silverio D, Sourlas A, Montan PD, Guzman E. Role of spironolactone in the treatment of heart failure with preserved ejection fraction. Ann Transl Med. 2018 Dec;6(23):461. doi: 10.21037/atm.2018.11.16.
PMID: 30603649
citation: Schrub F, Schnell F, Donal E, Galli E. Myocardial work is a predictor of exercise tolerance in patients with dilated cardiomyopathy and left ventricular dyssynchrony. Int J Cardiovasc Imaging. 2020 Jan;36(1):45-53. doi: 10.1007/s10554-019-01689-4. Epub 2019 Sep 12.
PMID: 31515694
citation: Galli E, Vitel E, Schnell F, Le Rolle V, Hubert A, Lederlin M, Donal E. Myocardial constructive work is impaired in hypertrophic cardiomyopathy and predicts left ventricular fibrosis. Echocardiography. 2019 Jan;36(1):74-82. doi: 10.1111/echo.14210. Epub 2018 Nov 29.
PMID: 30488501
citation: Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:
PMID: 27206819
citation: Moneghetti KJ, Kobayashi Y, Christle JW, Ariyama M, Vrtovec B, Kouznetsova T, Wilson A, Ashley E, Wheeler MT, Myers J, Haddad F. Contractile reserve and cardiopulmonary exercise parameters in patients with dilated cardiomyopathy, the two dimensions of exercise testing. Echocardiography. 2017 Aug;34(8):1179-1186. doi: 10.1111/echo.13623. Epub 2017 Jul 6.
PMID: 28681553
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Bernard Cosyns
investigator title: Head of Department
mesh term: Cardiotoxicity
sharing ipd: No