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/NCT05976477</url>
    </required_header>
    <id_info>
      <org_study_id>IRFMN-REPRESS-ONFOODS</org_study_id>
      <nct_id>NCT05976477</nct_id>
    </id_info>
    <brief_title>Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients</brief_title>
    <acronym>REPRESS</acronym>
    <official_title>Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mario Negri Institute for Pharmacological Research</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mario Negri Institute for Pharmacological Research</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>
        REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with&#xD;
        blinded endpoint with 1:1 (intervention to control arm) allocation ratio.&#xD;
  &#xD;
        The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at&#xD;
        reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed&#xD;
        to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>N/A</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>Other</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in systolic BP</measure>
      <time_frame>6 months</time_frame>
      <description>The primary outcome will be the change in systolic BP defined as the difference from baseline to 12 weeks follow-up in the two study groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in 24-hour urinary sodium excretion</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>The change in the level of 24-hour urinary sodium excretion as the difference from baseline to 12 weeks follow-up (short follow-up), or 6 and 12 months (long follow-up) in the two study arms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in adherence to the mediterranean diet</measure>
      <time_frame>6 and 12 months</time_frame>
      <description>The change in dietary habits of elderly patients during the 12 months follow-up in the two study groups measured by the adherence to Meditteranean Diet evaluated through the PREDIMED score (higher values correspond to better quality diet)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of cardio- and cerebro-vascular events</measure>
      <time_frame>12 months</time_frame>
      <description>The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">266</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to intervention arm during the 12 weeks after randomization will receive on their smartphone and/or via e-mail, information materials such as videos, images and recipes for reminders specifically designed to make patients aware on the importance of reducing dietary salt intake and suggestions on how to do it. The educational interventions will be delivered once a week. The main objective of the educational interventions is to spread knowledge about the health risks of excessive salt intake, the actual amount of salt in food, measures to reduce salt intake (e.g. use spices, eat fresh fruits and vegetables, check food labels, gradually reduce the salt in favorite recipes, avoid putting salt and salty sauces on the table, etc.). The interventions, conceived with nutritionists, will be delivered once a week to the participants and to their caregivers and/or the closest family member, involved in the food shopping and the preparation of meals.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients randomized to Control Group will only receive short tips on controlling blood pressure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>educational intervention</intervention_name>
      <description>four short videos (about one-minute/one-minute and half duration) concerning the topic of reducing dietary salt intake to control the blood pressure in elderly hypertensive patients: the mini-videos will be designed with a common thread starting from providing general information regarding diet to enhance awareness of the amount of salt that is usually introduced with the diet, up to give suggestions on which products to choose/avoid during grocery shopping and how to behave during the preparation and consumption of food at home to reduce salt intake;&#xD;
  Four images informing participants about the risk of excessive salt intake and health benefits of a low-sodium diet and tips on how to reduce daily salt intake;&#xD;
  Four recipes for tasty easy-to-prepare meals, avoiding added salt.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Community-dwelling patients aged ≥60 years;&#xD;
  &#xD;
            2. Prescribed ≥3 drugs;&#xD;
  &#xD;
            3. A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable&#xD;
               antihypertensive therapy (at least 1 drug (ATC code: C02*, C03*, C07*, C08*, C09*));&#xD;
               B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any&#xD;
               antihypertensive drug;&#xD;
  &#xD;
            4. Capable of feeding independently;&#xD;
  &#xD;
            5. Own a smartphone;&#xD;
  &#xD;
            6. Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the&#xD;
               weekend per month);&#xD;
  &#xD;
            7. Giving signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Living in a nursing home or having applied for nursing home admission;&#xD;
  &#xD;
            2. Being prescribed (adding, switching or changing dosage) an antihypertensive drug in&#xD;
               the three months before enrollment;&#xD;
  &#xD;
            3. Undergoing renal replacement therapy with dialysis or having renal impairment with&#xD;
               estimated glomerular filtration rate (eGFR) &lt;25 mL/min/1.73 m2 (assessed by CKD-EPI&#xD;
               formula) [30] within previous six months or at the screening assessment;&#xD;
  &#xD;
            4. Following a low-sodium dietary regimen;&#xD;
  &#xD;
            5. Being unable or refusing to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carlotta Franchi</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istituto di Ricerche Farmacologiche Mario Negri IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carlotta Franchi</last_name>
      <phone>+39 02 39014580</phone>
      <email>carlotta.franchi@marionegri.it</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mario Negri Institute for Pharmacological Research</investigator_affiliation>
      <investigator_full_name>Carlotta Franchi</investigator_full_name>
      <investigator_title>PRINCIPAL INVESTIGATOR</investigator_title>
    </responsible_party>
    <keyword>randomized controlled trial</keyword>
    <keyword>older patients</keyword>
    <keyword>polypharmacy</keyword>
    <keyword>diet</keyword>
    <keyword>salt intake</keyword>
    <keyword>educational intervention</keyword>
    <keyword>blood pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <!-- 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/NCT05976477
  org study id: IRFMN-REPRESS-ONFOODS
  nct id: NCT05976477
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  REPRESS is an open label, pragmatic, multicenter, randomized controlled phase III trial with
        blinded endpoint with 1:1 (intervention to control arm) allocation ratio.
  
        The REPRESS trial is aimed to determine the efficacy of an educational intervention aimed at
        reducing dietary salt intake in elderly people (60+) with moderate hypertension and exposed
        to polypharmacy (3+ drugs) in improving systolic BP control compared to an attention arm.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Care Provider, Outcomes Assessor)
  measure: Change in systolic BP
  time frame: 6 months
  description: The primary outcome will be the change in systolic BP defined as the difference from baseline to 12 weeks follow-up in the two study groups.
  measure: Change in 24-hour urinary sodium excretion
  time frame: 6 and 12 months
  description: The change in the level of 24-hour urinary sodium excretion as the difference from baseline to 12 weeks follow-up (short follow-up), or 6 and 12 months (long follow-up) in the two study arms
  measure: Change in adherence to the mediterranean diet
  time frame: 6 and 12 months
  description: The change in dietary habits of elderly patients during the 12 months follow-up in the two study groups measured by the adherence to Meditteranean Diet evaluated through the PREDIMED score (higher values correspond to better quality diet)
  measure: Incidence of cardio- and cerebro-vascular events
  time frame: 12 months
  description: The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm
  arm group label: Intervention
  arm group type: Experimental
  description: Patients randomized to intervention arm during the 12 weeks after randomization will receive on their smartphone and/or via e-mail, information materials such as videos, images and recipes for reminders specifically designed to make patients aware on the importance of reducing dietary salt intake and suggestions on how to do it. The educational interventions will be delivered once a week. The main objective of the educational interventions is to spread knowledge about the health risks of excessive salt intake, the actual amount of salt in food, measures to reduce salt intake (e.g. use spices, eat fresh fruits and vegetables, check food labels, gradually reduce the salt in favorite recipes, avoid putting salt and salty sauces on the table, etc.). The interventions, conceived with nutritionists, will be delivered once a week to the participants and to their caregivers and/or the closest family member, involved in the food shopping and the preparation of meals.
  arm group label: Control
  arm group type: No Intervention
  description: Patients randomized to Control Group will only receive short tips on controlling blood pressure.
  intervention type: Other
  intervention name: educational intervention
  description: four short videos (about one-minute/one-minute and half duration) concerning the topic of reducing dietary salt intake to control the blood pressure in elderly hypertensive patients: the mini-videos will be designed with a common thread starting from providing general information regarding diet to enhance awareness of the amount of salt that is usually introduced with the diet, up to give suggestions on which products to choose/avoid during grocery shopping and how to behave during the preparation and consumption of food at home to reduce salt intake;
  Four images informing participants about the risk of excessive salt intake and health benefits of a low-sodium diet and tips on how to reduce daily salt intake;
  Four recipes for tasty easy-to-prepare meals, avoiding added salt.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Carlotta Franchi
  role: Principal Investigator
  affiliation: Istituto di Ricerche Farmacologiche Mario Negri IRCCS
  last name: Carlotta Franchi
  phone: +39 02 39014580
  email: carlotta.franchi@marionegri.it
  responsible party type: Principal Investigator
  investigator affiliation: Mario Negri Institute for Pharmacological Research
  investigator full name: Carlotta Franchi
  investigator title: PRINCIPAL INVESTIGATOR
  mesh term: Hypertension