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

Hypertension Clinical Trial

— REPRESS  

Official title:

Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05976477
• Other study ID #: IRFMN-REPRESS-ONFOODS
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Mario Negri Institute for Pharmacological Research
• Contact: Carlotta Franchi
• Phone: +39 02 39014580
• Email: carlotta.franchi[@]marionegri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• educational intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 and 12 months
Secondary	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)	6 and 12 months
Secondary	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	12 months