<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/NCT02237820</url>
  </required_header>
  <id_info>
    <org_study_id>no specific protocol ID</org_study_id>
    <nct_id>NCT02237820</nct_id>
  </id_info>
  <brief_title>Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.</brief_title>
  <official_title>Dexamethasone Versus Prednisone in Heart Failure Patients, Hospitalized With Exacerbation of Chronic Obstructive Pulmonary Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with&#xD;
      negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF&#xD;
      patients hospitalized with exacerbation of COPD. The study may provide important data&#xD;
      regarding a simple but potentially robust intervention among large patient population with&#xD;
      high rates of hospital admissions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An Open-label randomized prospective study of HF patients (NYHA grade II-VI), hospitalized&#xD;
      with COPD exacerbation. Eighty patients will be randomized in a 1:1 fashion to conventional&#xD;
      and intervention testament groups. Informed consent will be obtained from all patients prior&#xD;
      to study enrolment.&#xD;
&#xD;
      Randomization will be performed using RED cap - secure web application. The conventional&#xD;
      therapy group will receive 40mg of oral prednisone daily, while the intervention group will&#xD;
      be treated with oral dexamethasone in an equivalent anti-inflammatory dose of 6 mg/day.&#xD;
      Glucocorticosteroids will be administered throughout hospitalization and will be continued&#xD;
      for at least 5-7 days. Dose changes through this period, as well as subsequent tapering will&#xD;
      be on the discretion of the treating physician. All patients will also be treated with&#xD;
      short-acting bronchodilators, antibiotics, oxygen, positive pressure non-invasive mechanical&#xD;
      ventilation and VTE prophylaxis - based on the GOLD 2019 guidelines and clinical judgment of&#xD;
      the attending physicians. An order for low sodium diet will be written. Discharge decisions&#xD;
      will be based on the GOLD 2019 discharge criteria list. Patients will be discharge without&#xD;
      steroid tapering regimen unless indicated by clinical judgment. Patient's demographic data&#xD;
      will be documented at baseline (age, sex, GOLD severity stage, data on hospitalizations in&#xD;
      the past year, patients' chronic drug therapy, Last spirometry and two-dimensional&#xD;
      echo-Doppler examination results).&#xD;
&#xD;
      On admission, patients' weight, height and oxygen saturation will be measured and routine&#xD;
      blood tests will be drawn for evaluation of complete blood count, chemistry, NT proBNP&#xD;
      levels, troponin, C-reactive protein and venous blood gas. Blood test results will be taken&#xD;
      from the patient electronic medical record and will be based on the tests taken in the ER and&#xD;
      during ward admission. Upon recruitment, the patient will be asked to complete COPD&#xD;
      assessment tool (CAT) questionnaire and the Kansas City Cardiomyopathy Questionnaire&#xD;
      (KCCQ-12, the short form version) in order to quantify their health status. A follow-up&#xD;
      telephone call visit will be performed 14±2 and 28±2 days after enrollment. The following&#xD;
      measures will be obtained: KCCQ-12 and CAT questionnaire scores and documentation of current&#xD;
      diuretic dose. After study completion, each patient will be followed for 30 more days post&#xD;
      admission in order to document further hospitalizations.&#xD;
&#xD;
      All the date collected during the study and after patients enrollment will be documented on a&#xD;
      specialized case report form (CRF) built on RED cap - secure web application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <phase>Phase 4</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>Length of hospital stay</measure>
    <time_frame>up to 1 month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in COPD assessment tool (CAT) questionnaire score</measure>
    <time_frame>Baseline, Week 2, Week 4</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score</measure>
    <time_frame>Baseline, Week 2, Week 4</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of re-admission</measure>
    <time_frame>30 days post enrollment</time_frame>
    <description>rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in diuretic doses</measure>
    <time_frame>Baseline, Week 2, Week 4</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Heart Failure</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Prednisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>6 mg/day of Oral Dexamethasone</description>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>40 mg/day of Oral Prednisone</description>
    <arm_group_label>Prednisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age &gt; 40 years.&#xD;
&#xD;
          -  Patients with a previous diagnosis of COPD and evidence of airflow limitation (GOLD&#xD;
             severity stage of II-IV).&#xD;
&#xD;
          -  Patients with COPD exacerbation and potential indications for hospitalization as&#xD;
             defined by the 2019 GOLD guidelines.&#xD;
&#xD;
          -  Patients with a diagnosis of heart failure (NYHA grade II-IV).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients with a severe exacerbation on enrollment, based upon arterial PH&lt;7.2 or PaCO2&#xD;
             &gt; 90 mmHg&#xD;
&#xD;
          -  Patients who are currently participating in other studies.&#xD;
&#xD;
          -  Known hypersensitivity to prednisone / dexamethasone.&#xD;
&#xD;
          -  Patients who were treated with systemic corticosteroids one month prior to admission,&#xD;
             unless prednisone dosage is 20 mg or less.&#xD;
&#xD;
          -  Patients who are unable to provide an informed consent.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
          -  Patients on Chronic mechanical ventilation.&#xD;
&#xD;
        Study drug treatment termination criteria:&#xD;
&#xD;
          -  Hypersensitivity reaction to prednisone / dexamethasone.&#xD;
&#xD;
          -  Any clinical deterioration, which at the discretion of the treating physician and/or&#xD;
             study investigators, necessitate change of the study steroid treatment (such as, but&#xD;
             not limited to, need to stop oral medication).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gideon Y Stein, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beilinson Hospital, Rabin Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ran Nissan, PharmD</last_name>
    <role>Study Director</role>
    <affiliation>Beilinson Hospital, Rabin Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa Cooper, MD</last_name>
    <role>Study Director</role>
    <affiliation>Beilinson Hospital, Rabin Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mordechai R Kramer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beilinson Hospital, Rabin Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shmuel Fuchs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beilinson Hospital, Rabin Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alon Y Grossman, MD</last_name>
    <phone>972-3-9376606</phone>
    <email>ALONG@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ran Nissan, PharmD</last_name>
    <phone>972-54-4892333</phone>
    <email>rnissan5@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beilinson Hospital, Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gideon Y Stein, MD PhD</last_name>
      <phone>972-3-9376606</phone>
      <email>gidi.stein@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ran Nissan, PharmD</last_name>
      <phone>972-54-4892333</phone>
      <email>rnissan5@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.</citation>
    <PMID>19168510</PMID>
  </reference>
  <reference>
    <citation>Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS-Lung Function Study Group. Chronic obstructive pulmonary disease in patients admitted with heart failure. J Intern Med. 2008 Oct;264(4):361-9. doi: 10.1111/j.1365-2796.2008.01975.x. Epub 2008 Jun 5.</citation>
    <PMID>18537871</PMID>
  </reference>
  <reference>
    <citation>Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS Lung Function Study Group. The prognostic importance of lung function in patients admitted with heart failure. Eur J Heart Fail. 2010 Jul;12(7):685-91. doi: 10.1093/eurjhf/hfq050. Epub 2010 Apr 15.</citation>
    <PMID>20395261</PMID>
  </reference>
  <reference>
    <citation>Schweiger TA, Zdanowicz M. Systemic corticosteroids in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Am J Health Syst Pharm. 2010 Jul 1;67(13):1061-9. doi: 10.2146/ajhp090293.</citation>
    <PMID>20554591</PMID>
  </reference>
  <reference>
    <citation>Maxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637.</citation>
    <PMID>21930637</PMID>
  </reference>
  <reference>
    <citation>Wei L, MacDonald TM, Walker BR. Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease. Ann Intern Med. 2004 Nov 16;141(10):764-70. doi: 10.7326/0003-4819-141-10-200411160-00007.</citation>
    <PMID>15545676</PMID>
  </reference>
  <reference>
    <citation>Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.</citation>
  </reference>
  <reference>
    <citation>Gardner D, Shoback D. Greenspan's basic &amp; clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.</citation>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Gideon Stein, md</investigator_full_name>
    <investigator_title>MD , PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisone</mesh_term>
  </intervention_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/NCT02237820
org study id: no specific protocol ID
nct id: NCT02237820
lead sponsor: 
has dmc: No
This is the first study assessing the impact of dexamethasone (a glucocorticosteroid with
      negligible mineralocorticoid activity) as compared to prednisone on short-term outcomes of HF
      patients hospitalized with exacerbation of COPD. The study may provide important data
      regarding a simple but potentially robust intervention among large patient population with
      high rates of hospital admissions.
An Open-label randomized prospective study of HF patients (NYHA grade II-VI), hospitalized
      with COPD exacerbation. Eighty patients will be randomized in a 1:1 fashion to conventional
      and intervention testament groups. Informed consent will be obtained from all patients prior
      to study enrolment.

      Randomization will be performed using RED cap - secure web application. The conventional
      therapy group will receive 40mg of oral prednisone daily, while the intervention group will
      be treated with oral dexamethasone in an equivalent anti-inflammatory dose of 6 mg/day.
      Glucocorticosteroids will be administered throughout hospitalization and will be continued
      for at least 5-7 days. Dose changes through this period, as well as subsequent tapering will
      be on the discretion of the treating physician. All patients will also be treated with
      short-acting bronchodilators, antibiotics, oxygen, positive pressure non-invasive mechanical
      ventilation and VTE prophylaxis - based on the GOLD 2019 guidelines and clinical judgment of
      the attending physicians. An order for low sodium diet will be written. Discharge decisions
      will be based on the GOLD 2019 discharge criteria list. Patients will be discharge without
      steroid tapering regimen unless indicated by clinical judgment. Patient's demographic data
      will be documented at baseline (age, sex, GOLD severity stage, data on hospitalizations in
      the past year, patients' chronic drug therapy, Last spirometry and two-dimensional
      echo-Doppler examination results).

      On admission, patients' weight, height and oxygen saturation will be measured and routine
      blood tests will be drawn for evaluation of complete blood count, chemistry, NT proBNP
      levels, troponin, C-reactive protein and venous blood gas. Blood test results will be taken
      from the patient electronic medical record and will be based on the tests taken in the ER and
      during ward admission. Upon recruitment, the patient will be asked to complete COPD
      assessment tool (CAT) questionnaire and the Kansas City Cardiomyopathy Questionnaire
      (KCCQ-12, the short form version) in order to quantify their health status. A follow-up
      telephone call visit will be performed 14±2 and 28±2 days after enrollment. The following
      measures will be obtained: KCCQ-12 and CAT questionnaire scores and documentation of current
      diuretic dose. After study completion, each patient will be followed for 30 more days post
      admission in order to document further hospitalizations.

      All the date collected during the study and after patients enrollment will be documented on a
      specialized case report form (CRF) built on RED cap - secure web application.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Length of hospital stay
time frame: up to 1 month
measure: Change in COPD assessment tool (CAT) questionnaire score
time frame: Baseline, Week 2, Week 4
measure: Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12 short form) score
time frame: Baseline, Week 2, Week 4
measure: Rate of re-admission
time frame: 30 days post enrollment
description: rate of respiratory deterioration necessitate intubation, re-admission or death at 30-day post enrollment
measure: Change from Baseline in diuretic doses
time frame: Baseline, Week 2, Week 4
arm group label: Dexamethasone
arm group type: Experimental
arm group label: Prednisone
arm group type: Active Comparator
intervention type: Drug
intervention name: Dexamethasone
description: 6 mg/day of Oral Dexamethasone
arm group label: Dexamethasone
intervention type: Drug
intervention name: Prednisone
description: 40 mg/day of Oral Prednisone
arm group label: Prednisone
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Gideon Y Stein, MD PhD
role: Principal Investigator
affiliation: Beilinson Hospital, Rabin Medical Center
last name: Ran Nissan, PharmD
role: Study Director
affiliation: Beilinson Hospital, Rabin Medical Center
last name: Lisa Cooper, MD
role: Study Director
affiliation: Beilinson Hospital, Rabin Medical Center
last name: Mordechai R Kramer, MD
role: Principal Investigator
affiliation: Beilinson Hospital, Rabin Medical Center
last name: Shmuel Fuchs, MD
role: Principal Investigator
affiliation: Beilinson Hospital, Rabin Medical Center
last name: Alon Y Grossman, MD
phone: 972-3-9376606
email: ALONG@gmail.com
last name: Ran Nissan, PharmD
phone: 972-54-4892333
email: rnissan5@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
citation: Hawkins NM, Petrie MC, Jhund PS, Chalmers GW, Dunn FG, McMurray JJ. Heart failure and chronic obstructive pulmonary disease: diagnostic pitfalls and epidemiology. Eur J Heart Fail. 2009 Feb;11(2):130-9. doi: 10.1093/eurjhf/hfn013.
PMID: 19168510
citation: Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS-Lung Function Study Group. Chronic obstructive pulmonary disease in patients admitted with heart failure. J Intern Med. 2008 Oct;264(4):361-9. doi: 10.1111/j.1365-2796.2008.01975.x. Epub 2008 Jun 5.
PMID: 18537871
citation: Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, Vestbo J, Kjoller E; ECHOS Lung Function Study Group. The prognostic importance of lung function in patients admitted with heart failure. Eur J Heart Fail. 2010 Jul;12(7):685-91. doi: 10.1093/eurjhf/hfq050. Epub 2010 Apr 15.
PMID: 20395261
citation: Schweiger TA, Zdanowicz M. Systemic corticosteroids in the treatment of acute exacerbations of chronic obstructive pulmonary disease. Am J Health Syst Pharm. 2010 Jul 1;67(13):1061-9. doi: 10.2146/ajhp090293.
PMID: 20554591
citation: Maxwell CB, Jenkins AT. Drug-induced heart failure. Am J Health Syst Pharm. 2011 Oct 1;68(19):1791-804. doi: 10.2146/ajhp100637.
PMID: 21930637
citation: Wei L, MacDonald TM, Walker BR. Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease. Ann Intern Med. 2004 Nov 16;141(10):764-70. doi: 10.7326/0003-4819-141-10-200411160-00007.
PMID: 15545676
citation: Global Initiative for Chronic Obstructive Lung Disease (GOLD). Updated 2013.
citation: Gardner D, Shoback D. Greenspan's basic & clinical endocrinology, 9 edition. McGraw-Hill Companies, Inc.
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Gideon Stein, md
investigator title: MD , PhD
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Heart Failure
mesh term: Dexamethasone
mesh term: Prednisone