xml: <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/NCT06022133</url>
    </required_header>
    <id_info>
      <org_study_id>BGH-5-2017</org_study_id>
      <secondary_id>1-10-72-253-17</secondary_id>
      <nct_id>NCT06022133</nct_id>
    </id_info>
    <brief_title>Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing</brief_title>
    <acronym>ROSA</acronym>
    <official_title>Sodium, Nocturnal Blood Pressure and Nocturnal Pauses in Breathing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jesper Norgaard Bech</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Regional Hospital Holstebro</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>
        A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular&#xD;
        disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular&#xD;
        disease. Patients with hypertension resistant of antihypertensive treatment have a high&#xD;
        frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to&#xD;
        analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal&#xD;
        pauses in breathing in this patients population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 3, 2018</start_date>
    <completion_date type="Actual">March 31, 2021</completion_date>
    <primary_completion_date type="Actual">March 31, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Binding not possible as patients needs to carry out dietary sodium restriction themselves.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in nocturnal systolic blood pressure</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of blood pressure measured by 24h blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of apnoea hypopnoea index measured by cardio respiratory monitoring at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in day:night sodium urinary sodium excretion</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)</measure>
      <time_frame>from day 14 to day 28</time_frame>
      <description>Comparison of biomarkers from blood samples drawn at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">16</enrollment>
    <condition>Sodium Imbalance</condition>
    <condition>Nocturnal Blood Pressure</condition>
    <condition>Obstructive Sleep Apnea of Adult</condition>
    <arm_group>
      <arm_group_label>Dietary sodium restriction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DIetary sodium restriction</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual diet</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual diet</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Dietary sodium restriction</intervention_name>
      <description>Selfemployed dietary sodium restriction</description>
      <arm_group_label>Dietary sodium restriction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  24h blood pressure &gt; 130/80 mmHg under antihypertensive treatment with three agent,&#xD;
               one of these being diuretic. Blood pressure measurement completed after observed&#xD;
               intake of antihypertensive medication.&#xD;
  &#xD;
            -  unchanged antihypertensive treatment for three months&#xD;
  &#xD;
            -  estimated glomerular function &gt;45 mL/min/1.73 m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Heart failure assessed from NYHA classification (grade 3-4)&#xD;
  &#xD;
            -  Presence of clinically significant peripheral edema&#xD;
  &#xD;
            -  In treatment for obstructive sleep apnea&#xD;
  &#xD;
            -  Chronic obstructive pulmonary disease (FEV1 &lt;50%)&#xD;
  &#xD;
            -  Antihypertensive therapy that can not be taken once daily&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Β-albumin &lt;34 g / l&#xD;
  &#xD;
            -  U-albumin creatinine ratio&gt; 1000 mg / g&#xD;
  &#xD;
            -  INR&gt; 1.2 (if marevan treatment: ALAT&gt; 200)&#xD;
  &#xD;
            -  Gluten allergy (dietary guidelines are not adjusted to this group)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bodil Hornstrup</last_name>
      <role>Principal Investigator</role>
      <affiliation>M.D., Ph.D.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University clinic in Nephrology and hypertension, Regional Hospital Godstrup</name>
        <address>
          <city>Godstrup</city>
          <state>Herning</state>
          <zip>7400</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Department of Medical Research and Medicine, Holstebro Regional Hospital</name>
        <address>
          <city>Holstebro</city>
          <zip>7500</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 23, 2020</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Regional Hospital Holstebro</investigator_affiliation>
      <investigator_full_name>Jesper Norgaard Bech</investigator_full_name>
      <investigator_title>M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022133
  org study id: BGH-5-2017
  secondary id: 1-10-72-253-17
  nct id: NCT06022133
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular
        disease.
  A reduction of dietary sodium intake reduces blood pressure and risk of cardiovascular
        disease. Patients with hypertension resistant of antihypertensive treatment have a high
        frequency of non-dipping and obstructive sleep apnoea (OSA). The aim of this project is to
        analyse the effect of dietary sodium restriction on nocturnal blood pressure and nocturnal
        pauses in breathing in this patients population.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  intervention model description: Not blinded cross over trial. First arm is usual diet for two weeks, second arm is sodium dietary restriction.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Binding not possible as patients needs to carry out dietary sodium restriction themselves.
  measure: Changes in nocturnal systolic blood pressure
  time frame: from day 14 to day 28
  description: Comparison of blood pressure measured by 24 hour blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  measure: Changes in day (systolic and diastolic) and 24h blood pressure (systolic and diastolic)
  time frame: from day 14 to day 28
  description: Comparison of blood pressure measured by 24h blood pressure measurements at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  measure: Changes in number of nocturnal pauses in breathing (apnoea hypopnoea index, AHI)
  time frame: from day 14 to day 28
  description: Comparison of apnoea hypopnoea index measured by cardio respiratory monitoring at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  measure: Changes in day:night sodium urinary sodium excretion
  time frame: from day 14 to day 28
  description: Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  measure: Changes in urinary excretion of aquaporin-2 (U-AQP2) og epithelial sodium channel (u-ENaCɣ)
  time frame: from day 14 to day 28
  description: Comparison of baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  measure: Changes in endothelial function (nitric oxide (NO), erythrocyte sodium sensitivity)
  time frame: from day 14 to day 28
  description: Comparison of biomarkers from blood samples drawn at baseline conditions (after two weeks of usual diet) and intervention (after two weeks of dietary sodium restriction)
  arm group label: Dietary sodium restriction
  arm group type: Experimental
  description: DIetary sodium restriction
  arm group label: Usual diet
  arm group type: No Intervention
  description: Usual diet
  intervention type: Behavioral
  intervention name: Dietary sodium restriction
  description: Selfemployed dietary sodium restriction
  arm group label: Dietary sodium restriction
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Bodil Hornstrup
  role: Principal Investigator
  affiliation: M.D., Ph.D.
  facility: 
  facility: 
  country: Denmark
  responsible party type: Sponsor-Investigator
  investigator affiliation: Regional Hospital Holstebro
  investigator full name: Jesper Norgaard Bech
  investigator title: M.D., PhD, head of University Clinic in Nephrology and Hypertension, Regeional Hospital Vest Justland and Aarhus university
  mesh term: Sleep Apnea, Obstructive
  sharing ipd: No