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

Mario Negri Institute for Pharmacological Research

Status: Not yet enrolling

Conditions: Hypertension

Treatments: Other: educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05976477

IRFMN-REPRESS-ONFOODS

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Community-dwelling patients aged ≥60 years;
2. Prescribed ≥3 drugs;
3. 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;
4. Capable of feeding independently;
5. Own a smartphone;
6. Frequently consuming home-cooked meals (≥4 days during a week and ≥3 during the weekend per month);
7. Giving signed informed consent.

Exclusion criteria

1. Living in a nursing home or having applied for nursing home admission;
2. Being prescribed (adding, switching or changing dosage) an antihypertensive drug in the three months before enrollment;
3. 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;
4. Following a low-sodium dietary regimen;
5. Being unable or refusing to sign informed consent.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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266 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Other: educational intervention

Control

No Intervention group

Description:

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