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

NCT05976477 | Unknown

• 1 other identifier: IRFMN-REPRESS-ONFOODS
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

randomized controlled trial; older patients; polypharmacy; diet; salt intake; educational intervention; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Change in 24-hour urinary sodium excretion

  6 and 12 months

• Change in adherence to the mediterranean diet

  6 and 12 months

• Incidence of cardio- and cerebro-vascular events

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: educational intervention

Control

NO INTERVENTION

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

Interventions

educational intervention OTHER

1. 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; 2. 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; 3. Four recipes for tasty easy-to-prepare meals, avoiding added salt.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

MeSH Terms

Conditions

Hypertension

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Carlotta Franchi

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlotta Franchi

CONTACT

+39 02 39014580; carlotta.franchi@marionegri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: August 4, 2023
• Study Start: October 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08