<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/NCT04441346</url>
  </required_header>
  <id_info>
    <org_study_id>CHF in Dialysis patients</org_study_id>
    <nct_id>NCT04441346</nct_id>
  </id_info>
  <brief_title>Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients</brief_title>
  <official_title>Frequency and Risk Factors of Congestive Heart Failure in Dialysis Patients Attending Assiut University Hosptial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <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 aims :&#xD;
&#xD;
      To assess the frequency of heart failure in patients with end-stage renal disease on regular&#xD;
      dialysis.&#xD;
&#xD;
      To identify the risk factors of heart failure in patients with end-stage renal disease.&#xD;
&#xD;
      To assess the impact of duration of dialysis on heart failure and its prognosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart Failure is defined as a complex clinical syndrome that can result from any structural&#xD;
      or functional cardiac disorder that impairs the ability of the ventricle to fill or eject&#xD;
      blood with diagnosis relying on clinical examination and associated with significant&#xD;
      mortality and morbidity. Congestive heart failure (CHF) is a cardiovascular complication in&#xD;
      which the heart becomes unable to supply a sufficient amount of blood to meet the metabolic&#xD;
      requirements and fulfill the body's oxygen demand.&#xD;
&#xD;
      CHF is an independent risk factor for early mortality in ESRD patients. More than half of all&#xD;
      deaths among ESRD patients are due to cardiovascular disease (CVD). Cardiovascular changes&#xD;
      secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary&#xD;
      hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut&#xD;
      microbiota-derived uremic toxins like trimethylamine N-oxidase (TMAO), contribute to the high&#xD;
      risk for CVD in the ESRD population. Also, conventional hemodialysis (HD) itself poses&#xD;
      myocardial stress and injury to the already compromised cardiovascular system in uremic&#xD;
      patients.&#xD;
&#xD;
      The characteristics of cardiovascular dysfunction observed in dialysis patients are distinct&#xD;
      from those noted in the general population. Although traditional cardiovascular risk factors&#xD;
      in patients with end-stage renal disease (ESRD) are highly prevalent, they play only a&#xD;
      partial role in the excessive cardiovascular morbidity and mortality of this population. The&#xD;
      paradoxical association between several traditional risk factors, such as body mass index,&#xD;
      blood pressure (BP) and serum cholesterol, and mortality have been previously reported.&#xD;
&#xD;
      In the ESRD population, Hemodialysis (HD) contributes itself to the development of CHF with&#xD;
      sustained fluid overload a major cause of hypertension, heart failure, and mortality in&#xD;
      patients with ESRD. We postulate that repeated myocardial micro-injury during maintenance&#xD;
      hemodialysis may lead to irreversible cardiac dysfunction and subsequent heart failure and&#xD;
      death in some patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>risk factors of CHF in hemodialysis patients</measure>
    <time_frame>July 2020 to July 2021</time_frame>
    <description>identification of risk factors using demographic and disease characteristics of the patient as age, gender, systolic and diastolic blood pressure, dialysis access, frequency and duration of HD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of CHF in hemodialysis patients</measure>
    <time_frame>July 2020 to July 2021</time_frame>
    <description>identification of CHF in ESRD patients using echocardiography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>impact of duration of dialysis on heart failure</measure>
    <time_frame>July 2020 to July 2021</time_frame>
    <description>determine the extent of CHF in relation to duration of dialysis</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">289</enrollment>
  <condition>Congestive Heart Failure</condition>
  <arm_group>
    <arm_group_label>patients with recent hemodialysis(less than 6 month</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients on hemodialysis more than 6 months and l</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients on hemodialysis more than 5 years</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>test that uses high frequency sound waves (ultrasound) to make pictures of your heart.</description>
    <arm_group_label>patients on hemodialysis more than 5 years</arm_group_label>
    <arm_group_label>patients on hemodialysis more than 6 months and l</arm_group_label>
    <arm_group_label>patients with recent hemodialysis(less than 6 month</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Dialysis unit of Internal Medicine Department in Assiut University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ESRD patient on regular hemodialysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AKI patients on HD&#xD;
&#xD;
          -  Patients discontinued therapy during the study period will be excluded.&#xD;
&#xD;
          -  Patients with structural heart disease (congenital or valvular heart disease)&#xD;
&#xD;
          -  Patients with obstructive or restrictive lung diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Esraa Galal</last_name>
    <phone>0201094424433</phone>
    <email>esraagalal.eg@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dina Ali, DR</last_name>
    <phone>0201063040703</phone>
    <email>dinaalihamad@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Esraa Galal</investigator_full_name>
    <investigator_title>Resident Doctor, internal medicine department, principal investigator</investigator_title>
  </responsible_party>
  <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/NCT04441346
org study id: CHF in Dialysis patients
nct id: NCT04441346
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims :

      To assess the frequency of heart failure in patients with end-stage renal disease on regular
      dialysis.

      To identify the risk factors of heart failure in patients with end-stage renal disease.

      To assess the impact of duration of dialysis on heart failure and its prognosis
Heart Failure is defined as a complex clinical syndrome that can result from any structural
      or functional cardiac disorder that impairs the ability of the ventricle to fill or eject
      blood with diagnosis relying on clinical examination and associated with significant
      mortality and morbidity. Congestive heart failure (CHF) is a cardiovascular complication in
      which the heart becomes unable to supply a sufficient amount of blood to meet the metabolic
      requirements and fulfill the body's oxygen demand.

      CHF is an independent risk factor for early mortality in ESRD patients. More than half of all
      deaths among ESRD patients are due to cardiovascular disease (CVD). Cardiovascular changes
      secondary to renal dysfunction, including fluid overload, uremic cardiomyopathy, secondary
      hyperparathyroidism, anemia, altered lipid metabolism, and accumulation of gut
      microbiota-derived uremic toxins like trimethylamine N-oxidase (TMAO), contribute to the high
      risk for CVD in the ESRD population. Also, conventional hemodialysis (HD) itself poses
      myocardial stress and injury to the already compromised cardiovascular system in uremic
      patients.

      The characteristics of cardiovascular dysfunction observed in dialysis patients are distinct
      from those noted in the general population. Although traditional cardiovascular risk factors
      in patients with end-stage renal disease (ESRD) are highly prevalent, they play only a
      partial role in the excessive cardiovascular morbidity and mortality of this population. The
      paradoxical association between several traditional risk factors, such as body mass index,
      blood pressure (BP) and serum cholesterol, and mortality have been previously reported.

      In the ESRD population, Hemodialysis (HD) contributes itself to the development of CHF with
      sustained fluid overload a major cause of hypertension, heart failure, and mortality in
      patients with ESRD. We postulate that repeated myocardial micro-injury during maintenance
      hemodialysis may lead to irreversible cardiac dysfunction and subsequent heart failure and
      death in some patients.
observational model: Cohort
time perspective: Prospective
measure: risk factors of CHF in hemodialysis patients
time frame: July 2020 to July 2021
description: identification of risk factors using demographic and disease characteristics of the patient as age, gender, systolic and diastolic blood pressure, dialysis access, frequency and duration of HD
measure: incidence of CHF in hemodialysis patients
time frame: July 2020 to July 2021
description: identification of CHF in ESRD patients using echocardiography
measure: impact of duration of dialysis on heart failure
time frame: July 2020 to July 2021
description: determine the extent of CHF in relation to duration of dialysis
arm group label: patients with recent hemodialysis(less than 6 month
arm group label: patients on hemodialysis more than 6 months and l
arm group label: patients on hemodialysis more than 5 years
intervention type: Radiation
intervention name: Echocardiography
description: test that uses high frequency sound waves (ultrasound) to make pictures of your heart.
arm group label: patients on hemodialysis more than 5 years
arm group label: patients on hemodialysis more than 6 months and l
arm group label: patients with recent hemodialysis(less than 6 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Esraa Galal
phone: 0201094424433
email: esraagalal.eg@gmail.com
last name: Dina Ali, DR
phone: 0201063040703
email: dinaalihamad@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Esraa Galal
investigator title: Resident Doctor, internal medicine department, principal investigator
mesh term: Heart Failure