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Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients (REPRESS)

Primary Purpose

Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational intervention
Sponsored by
Mario Negri Institute for Pharmacological Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring randomized controlled trial, older patients, polypharmacy, diet, salt intake, educational intervention, blood pressure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Community-dwelling patients aged ≥60 years; Prescribed ≥3 drugs; A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable antihypertensive therapy (at least 1 drug (ATC code: C02*, C03*, C07*, C08*, C09*)); B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any antihypertensive drug; Capable of feeding independently; Own a smartphone; Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month); Giving signed informed consent. Exclusion Criteria: Living in a nursing home or having applied for nursing home admission; Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment; Undergoing renal replacement therapy with dialysis or having renal impairment with estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2 (assessed by CKD-EPI formula) [30] within previous six months or at the screening assessment; Following a low-sodium dietary regimen; Being unable or refusing to sign informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm 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.

    Patients randomized to Control Group will only receive short tips on controlling blood pressure.

    Outcomes

    Primary Outcome Measures

    Change in systolic BP
    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.

    Secondary Outcome Measures

    Change in 24-hour urinary sodium excretion
    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
    Change in adherence to the mediterranean diet
    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)
    Incidence of cardio- and cerebro-vascular events
    The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Mario Negri Institute for Pharmacological Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05976477
    Brief Title
    Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients
    Acronym
    REPRESS
    Official Title
    Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mario Negri Institute for Pharmacological Research

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    randomized controlled trial, older patients, polypharmacy, diet, salt intake, educational intervention, blood pressure

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    266 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to Control Group will only receive short tips on controlling blood pressure.
    Intervention Type
    Other
    Intervention Name(s)
    educational intervention
    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.
    Primary Outcome Measure Information:
    Title
    Change in systolic BP
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in 24-hour urinary sodium excretion
    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
    Time Frame
    6 and 12 months
    Title
    Change in adherence to the mediterranean diet
    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)
    Time Frame
    6 and 12 months
    Title
    Incidence of cardio- and cerebro-vascular events
    Description
    The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Community-dwelling patients aged ≥60 years; Prescribed ≥3 drugs; A) Systolic blood pressure ≥130 and ≤160 mmHg for patients prescribed stable antihypertensive therapy (at least 1 drug (ATC code: C02*, C03*, C07*, C08*, C09*)); B) Systolic blood pressure ≥140 and ≤160 mmHg for those patients not prescribed any antihypertensive drug; Capable of feeding independently; Own a smartphone; Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month); Giving signed informed consent. Exclusion Criteria: Living in a nursing home or having applied for nursing home admission; Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment; Undergoing renal replacement therapy with dialysis or having renal impairment with estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2 (assessed by CKD-EPI formula) [30] within previous six months or at the screening assessment; Following a low-sodium dietary regimen; Being unable or refusing to sign informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carlotta Franchi
    Phone
    +39 02 39014580
    Email
    carlotta.franchi@marionegri.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carlotta Franchi
    Organizational Affiliation
    Istituto di Ricerche Farmacologiche Mario Negri IRCCS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients

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