<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/NCT02186405</url>
  </required_header>
  <id_info>
    <org_study_id>14-AOI-03</org_study_id>
    <nct_id>NCT02186405</nct_id>
  </id_info>
  <brief_title>Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism</brief_title>
  <official_title>Effects of Levothyroxine Treatment on Hemodynamic and Isotopic Renal Functions in Subclinical Hypothyroidism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and&#xD;
      normal T4 are less known and the indications for treatment of subclinical hypothyroidism are&#xD;
      subject to controversies.&#xD;
&#xD;
      The investigators propose to assess whether the hormone replacement for subclinical&#xD;
      hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and&#xD;
      renal functions and which mechanisms are involved.&#xD;
&#xD;
      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic&#xD;
      evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried&#xD;
      out before and 6 months after substitution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. In&#xD;
      human, exact measurements of GFR showed a decline in GFR after thyroidectomy and an increase&#xD;
      in GFR and renal blood flow after hormone replacement. Renal and cardiovascular effects of&#xD;
      subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the&#xD;
      indications for treatment of subclinical hypothyroidism are subject to controversies. A&#xD;
      retrospective study suggests that treatment of subclinical hypothyroidism may slow the&#xD;
      degradation rate of renal function estimated by MDRD. However, the potential hemodynamic&#xD;
      benefit of treatment has not yet been studied.&#xD;
&#xD;
      The investigators propose to assess whether the hormone replacement for subclinical&#xD;
      hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and&#xD;
      renal functions and which mechanisms are involved.&#xD;
&#xD;
      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic&#xD;
      evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried&#xD;
      out before and 6 months after substitution. This open prospective study will include 16&#xD;
      patients in order to detect an increase of 1.2 standard deviation for the measured glomerular&#xD;
      filtration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patient corresponding to inclusion criteria couldn't be enrolled in the study&#xD;
  </why_stopped>
  <start_date>October 2015</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>KIDNEY CLEARANCE</measure>
    <time_frame>Before treatment and 6 months after treatment</time_frame>
    <description>(51)Cr-EDTA clearance after 6 months of hormonal replacement</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Subclinical hypothyroïdism</condition>
  <arm_group>
    <arm_group_label>LEVOTHYROXINE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administration of levothyroxine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LEVOTHYROXINE</intervention_name>
    <description>administration of levothyroxine</description>
    <arm_group_label>LEVOTHYROXINE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years&#xD;
&#xD;
          -  chronic kidney disease&#xD;
&#xD;
          -  subclinical hypothyroidism&#xD;
&#xD;
        non-inclusion Criteria:&#xD;
&#xD;
          -  insulin-dependent diabetes&#xD;
&#xD;
          -  dialysis&#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>Guillaume FAVRE, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nephrology Department</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>October 27, 2016</last_update_submitted>
  <last_update_submitted_qc>October 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 28, 2016</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>Hypothyroidism</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/NCT02186405
org study id: 14-AOI-03
nct id: NCT02186405
lead sponsor: 
has dmc: No
Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and
      normal T4 are less known and the indications for treatment of subclinical hypothyroidism are
      subject to controversies.

      The investigators propose to assess whether the hormone replacement for subclinical
      hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and
      renal functions and which mechanisms are involved.

      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic
      evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried
      out before and 6 months after substitution.
Animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. In
      human, exact measurements of GFR showed a decline in GFR after thyroidectomy and an increase
      in GFR and renal blood flow after hormone replacement. Renal and cardiovascular effects of
      subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the
      indications for treatment of subclinical hypothyroidism are subject to controversies. A
      retrospective study suggests that treatment of subclinical hypothyroidism may slow the
      degradation rate of renal function estimated by MDRD. However, the potential hemodynamic
      benefit of treatment has not yet been studied.

      The investigators propose to assess whether the hormone replacement for subclinical
      hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and
      renal functions and which mechanisms are involved.

      Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic
      evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried
      out before and 6 months after substitution. This open prospective study will include 16
      patients in order to detect an increase of 1.2 standard deviation for the measured glomerular
      filtration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: KIDNEY CLEARANCE
time frame: Before treatment and 6 months after treatment
description: (51)Cr-EDTA clearance after 6 months of hormonal replacement
arm group label: LEVOTHYROXINE
arm group type: Experimental
description: administration of levothyroxine
intervention type: Drug
intervention name: LEVOTHYROXINE
description: administration of levothyroxine
arm group label: LEVOTHYROXINE
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume FAVRE, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
facility: 
country: France
responsible party type: Sponsor
mesh term: Hypothyroidism