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

Not Applicable

Not yet recruiting

• Conditions: Hypertension

• Registration Number: NCT05976477
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-07-27
• Status Verified: 2023-08
• Study First Posted: 2023-08-04
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01
• Study Start: 2023-10-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 266

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in systolic BP	6 months	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

Name	Time	Method
Change in 24-hour urinary sodium excretion	6 and 12 months	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	6 and 12 months	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	12 months	The difference in the incidence of cardio- and cerebro-vascular events during 12-months follow-up between the intervention and the control arm