HypertensionREPRESSNCT05976477
Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients
A study testing educational intervention in people with Hypertension, run by Mario Negri Institute for Pharmacological Research.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial
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
- Being tested
- educational intervention
- Keywords
- randomized controlled trial, older patients, polypharmacy, diet, salt intake, educational intervention, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: educational intervention |
| Control | No intervention | Patients randomized to Control Group will only receive short tips on controlling blood pressure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 6 and 12 months
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)
Measured: 6 and 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlotta Franchi, Mario Negri Institute for Pharmacological Research
- Investigators
- Carlotta Franchi, Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976477
- Sponsor's protocol ID
- IRFMN-REPRESS-ONFOODS
- Acronym
- REPRESS
- Status last verified
- Aug 2023
- First submitted
- 11 Apr 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction Of Dietary Salt Intake To Control Systolic Blood Pressure In Hypertensive Older Patients: The Repress Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05976477
- Acronym / sponsor ID
- REPRESS / IRFMN-REPRESS-ONFOODS
- Conditions
- Hypertension
- Keywords
- randomized controlled trial, older patients, polypharmacy, diet, salt intake, educational intervention, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: educational interventionPatients 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. |
| Control | No intervention | –Patients randomized to Control Group will only receive short tips on controlling blood pressure. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational intervention1. 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. | Other | Intervention |
Primary outcome
Change in systolic BP
Time frame: 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.
3 secondary outcomes
Change in 24-hour urinary sodium excretion
Time frame: 6 and 12 months
Change in adherence to the mediterranean diet
Time frame: 6 and 12 months
Incidence of cardio- and cerebro-vascular events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlotta Franchi principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Hypertension, run by Mario Negri Institute for Pharmacological Research.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlotta Franchi (+39 02 39014580, carlotta.franchi@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic BP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.