<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/NCT03255044</url>
  </required_header>
  <id_info>
    <org_study_id>48</org_study_id>
    <nct_id>NCT03255044</nct_id>
  </id_info>
  <brief_title>Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure</brief_title>
  <official_title>Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      There is a controversy whether statins are beneficial in patients with heart failure or not.&#xD;
      Trials in which lipophilic statins have been used revealed positive results, unlike major&#xD;
      studies where hydrophilic statins were administered. This trial is designed to compare the&#xD;
      effects of lipophilic versus hydrophilic statin use in patients with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">April 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular Ejection Fraction (LVEF)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular End-diastolic volume (LVEDV)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Ventricular End-systolic volume (LVESV)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>cardiac markers</measure>
    <time_frame>6 months</time_frame>
    <description>NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minnesota Living with Heart Failure Questionnaire( MLHFQ)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Packer composite outcome</measure>
    <time_frame>6 months</time_frame>
    <description>Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment: markedly/moderately improved (or both) but did not experience any major adverse clinical events during the course of the trial (death or hospitalization).&#xD;
Patients are considered worse if they experienced a major clinical event during the duration of treatment or reported worsening of their NYHA class or global assessment at the final visit.&#xD;
Patients are considered unchanged if they are neither improved nor worse.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of major adverse cardiac events</measure>
    <time_frame>6 months</time_frame>
    <description>Cardiovascular death&#xD;
All cause death&#xD;
Non- fatal myocardial infarction&#xD;
Stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of Hospitalization</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Lipophilic statin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrophilic statin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin administered as well as standard heart failure therapy</description>
    <arm_group_label>Lipophilic statin</arm_group_label>
    <other_name>standard heart failure therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Rosuvastatin administered as well as standard heart failure therapy</description>
    <arm_group_label>Hydrophilic statin</arm_group_label>
    <other_name>standard heart failure therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>guideline directed therapy</intervention_name>
    <description>standard heart failure therapy</description>
    <arm_group_label>Hydrophilic statin</arm_group_label>
    <arm_group_label>Lipophilic statin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  older than 18 years (of both sexes)&#xD;
&#xD;
          -  diagnosed with stable chronic heart failure NYHA class II-III&#xD;
&#xD;
          -  ejection fraction &lt; 40 % as assessed by 2D echocardiography&#xD;
&#xD;
          -  who have been optimized on Guideline Directed treatment for heart failure for at least&#xD;
             a month prior to enrolling.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to statin&#xD;
&#xD;
          -  Treatment with statins during the past month prior to study.&#xD;
&#xD;
          -  Serum creatinine &gt; 3 mg/dl&#xD;
&#xD;
          -  Significant liver disease: liver enzymes 2.5 folds the upper normal limit&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University Hospital Cardiology Rehab Unit</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Nouran Omar</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <keyword>statin</keyword>
  <keyword>hydrophilic</keyword>
  <keyword>lipophilic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_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/NCT03255044
org study id: 48
nct id: NCT03255044
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a controversy whether statins are beneficial in patients with heart failure or not.
      Trials in which lipophilic statins have been used revealed positive results, unlike major
      studies where hydrophilic statins were administered. This trial is designed to compare the
      effects of lipophilic versus hydrophilic statin use in patients with heart failure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Left Ventricular Ejection Fraction (LVEF)
time frame: 6 months
measure: Left Ventricular End-diastolic volume (LVEDV)
time frame: 6 months
measure: Left Ventricular End-systolic volume (LVESV)
time frame: 6 months
measure: cardiac markers
time frame: 6 months
description: NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
measure: Minnesota Living with Heart Failure Questionnaire( MLHFQ)
time frame: 6 months
measure: Packer composite outcome
time frame: 6 months
description: Patients are considered improved if at the final visit they experienced a favorable change in NYHA functional class or in the patient global assessment: markedly/moderately improved (or both) but did not experience any major adverse clinical events during the course of the trial (death or hospitalization).
Patients are considered worse if they experienced a major clinical event during the duration of treatment or reported worsening of their NYHA class or global assessment at the final visit.
Patients are considered unchanged if they are neither improved nor worse.
measure: Incidence of major adverse cardiac events
time frame: 6 months
description: Cardiovascular death
All cause death
Non- fatal myocardial infarction
Stroke
measure: Incidence of Hospitalization
time frame: 6 months
description: Defined as hospitalization for worsening of heart failure for more than 24 hours and demanding aggressive intervention (IV inotropics, diuretics etc..)
arm group label: Lipophilic statin
arm group type: Active Comparator
description: Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
arm group label: Hydrophilic statin
arm group type: Active Comparator
description: Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin administered as well as standard heart failure therapy
arm group label: Lipophilic statin
other name: standard heart failure therapy
intervention type: Drug
intervention name: Rosuvastatin
description: Rosuvastatin administered as well as standard heart failure therapy
arm group label: Hydrophilic statin
other name: standard heart failure therapy
intervention type: Other
intervention name: guideline directed therapy
description: standard heart failure therapy
arm group label: Hydrophilic statin
arm group label: Lipophilic statin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Nouran Omar
investigator title: Assistant Lecturer
mesh term: Heart Failure
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
sharing ipd: No