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Blood PressurePhase 2COSIP-1NCT02738736

Clarifying Optimal Sodium Intake Project

A Phase 2 study testing Sodium Reduction in people with Blood Pressure and Hypertension, run by University College Hospital Galway at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key determinant of blood pressure, and reducing sodium intake has emerged as an important target for population-based interventions to prevent CVD. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Blood Pressure, Hypertension, Kidney Disease
What is being tested?
Sodium Reduction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
1 siteIreland
Study dates
Apr 2016to Aug 2020
Phase
Phase 2
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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 40 years or older
  • Systolic blood pressure <160mmHg and diastolic blood pressure <95mmHg on three office blood pressure readings at time of screening and confirmed by a study ABPM before randomization of <150/90mmHg
  • No change in anti-hypertensive or diuretic medications (including dose) for 3 months before screening visit
  • Consumption of moderate sodium intake at screening, defined as an estimated daily sodium intake of >2.3/day estimated from food frequency questionnaire (FFQ)
  • Self-reported willingness to modify dietary intake over sustained period, and adhere with directed recommendations over 2 years.
  • Signed written informed consent

Who cannot join

  • Known chronic kidney disease (CKD) or most recent eGFR ≤60ml/min/1.73m2
  • Participants who are ineligible for COSIP based on their eGFR will be approached about entering the ongoing Sodium Intake in Chronic Kidney Disease (STICK) trial.
  • Previous cardiovascular disease:
  • Myocardial infarction
  • Previous percutaneous coronary intervention (PCI) or percutaneous transluminal coronary angioplasty (PTCA)
  • Stroke (previous transient ischaemic attack [TIA] is not an exclusion criterion)
Show all 23Show fewer
  • Medical diagnosis known to be associated with abnormal renal sodium excretion, including the following:
  • Bartter syndrome
  • SIADH
  • Diabetes insipidus
  • Serum sodium <125mmol
  • Severe heart failure defined as NYHA Class III/IV OR left ventricular ejection fraction (LVEF) ≤30%
  • High-dose loop or thiazide diuretic therapy, exceeding a total daily dose of frusemide 80mg, bumetanide 2mg, hydrochlorothiazide 50mg, bendroflumethiazide 2.5mg, indapamide 2.5mg, metolazone 2.5mg or the use of both a loop and thiazide diuretic
  • Unable to follow educational advice of the research team
  • Prescribed high-salt diet, low-salt diet or sodium bicarbonate
  • Symptomatic postural hypotension or receiving treatment for postural hypotension
  • Current or recent use (within one month) of immunosuppressive medications including tacrolimus, cyclosporine, azathioprine or mycophenolate mofetil
  • Pregnancy or lactation
  • Unable to comply with 24-hour urinary collections, or medical condition making collection of 24-hour urinary collection difficult (e.g. severe urinary incontinence)
  • Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in the opinion of the research team
  • Cognitive impairment defined as a known diagnosis of dementia or inability to provide informed consent due to cognitive impairment in the opinion of the investigator
  • Body Mass Index (BMI) <20 kg/m2 or BMI>40 kg/m2
  • Participating in another clinical trial or previous allocation in this study

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • HRB Clinical Research Facility Galway

    Galway

Other trials in Ireland

About this study

Official title: Clarifying Optimal Sodium Intake Project- Objective 1

Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key determinant of blood pressure, and reducing sodium intake has emerged as an important target for population-based interventions to prevent CVD. However, there is considerable uncertainty about the optimal level of sodium intake that is associated with lowest CV risk, and whether optimal levels differ for different populations and individuals. International and national guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons, and advocate a population-wide approach to reducing sodium. Most of the world's population (~95%) consume between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most people will require a major change to their diet, to achieve the guideline target (<2g/day). While there is convincing evidence that high sodium intake (>5g/day) is associated with an increased risk of CVD, compared to low or moderate intake, the evidence that low sodium intake (<2.0g/day) is associated with a lower risk of CVD than moderate intake (2.0-5g/day) is inconsistent and inconclusive. The investigators plan to conduct a Phase IIb clinical trial to evaluate the role of low sodium intake (versus moderate) on cardiovascular biomarkers.

Being tested
Sodium Reduction
Medical subject headings
Hypertension, Kidney Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium ReductionBehavioural

    In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all specified post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day). A research dietitian will develop the specific components of the intervention, based on standardised approaches to education interventions

Study groups in NCT02738736
Study groupRoleWhat they receive
Sodium ReductionExperimentalIn addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day).
Receives: Behavioral: Sodium Reduction
Usual CareNo interventionParticipants randomized to usual care will also attend a dietitian-developed healthy eating guidance session but will not receive specific recommendations targeting sodium intake.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in cardiovascular biomarkers (Renin)

    Change in renin from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

    Measured: 24 months

  2. Change in cardiovascular biomarkers (Aldosterone)

    Change in aldosterone from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

    Measured: 24 months

  3. Change in cardiovascular biomarkers (Troponin T)

    Change in troponin T from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

    Measured: 24 months

  4. Change in cardiovascular biomarkers (Pro-BNP)

    Change in Pro-BNP from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

    Measured: 24 months

  5. Change in cardiovascular biomarkers ( C-reactive protein)

    Change in C-reactive protein from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

    Measured: 24 months

Secondary outcomes (8)

  1. Change in 24-hour urinary sodium excretion

    Change in 24-hour urinary sodium excretion from baseline to final visit (two years)

    Measured: 24 months

  2. Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring

    Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit (two years)

    Measured: 24 months

  3. Change in functional status as measured by the assessment functional status questionnaire

    Measured: 24 months

  4. Change in eGFR (MDRD formula)

    Change in eGFR (MDRD formula) from baseline to final follow-up

    Measured: 24 months

  5. Change in eGFR(CKD-EPI formula)

    Change in eGFR (CKD-EPI formula) from baseline to final follow-up

    Measured: 24 months

  6. Change in RNA measured through PAXgene RNA blood samples

    Measured: 24 months

  7. Number of recorded falls, syncope and pre-syncope

    Measured: 24 months

  8. Number of cardiovascular events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionAug 2020
  4. Study completionAug 2020

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738736
Sponsor's protocol ID
HRBCRFG-010416
Acronym
COSIP-1
Status last verified
Apr 2021
First submitted
4 Apr 2016
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Smyth A, Judge C, Kerins C, McDermott S, Niland A, Corcoran C, Dineen R, Alvarez-Iglesias A, Nolan A, Mente A, Griffin MD, O'Shea P, Canavan M, Yusuf S, O'Donnell M. Dietary counselling to reduce moderate sodium intake: effects on cardiovascular and renal biomarkers: primary findings of the COSIP and STICK phase II feasibility randomised controlled trials. EClinicalMedicine. 2023 Feb 15;57:101856. doi: 10.1016/j.eclinm.2023.101856. eCollection 2023 Mar.

    PubMed 37064508

  • Smyth A, Yusuf S, Kerins C, Corcoran C, Dineen R, Alvarez-Iglesias A, Ferguson J, McDermott S, Hernon O, Ranjan R, Nolan A, Griffin M, O'Shea P, Canavan M, O'Donnell M. Clarifying Optimal Sodium InTake In Cardiovasular and Kidney (COSTICK) Diseases: a study protocol for two randomised controlled trials. HRB Open Res. 2022 Feb 7;4:14. doi: 10.12688/hrbopenres.13210.2. eCollection 2021.

    PubMed 36348660

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sodium Reduction in people with Blood Pressure and Hypertension, run by University College Hospital Galway at 1 site in Ireland.

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 6 inclusion and 23 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: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cardiovascular biomarkers (Renin) (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738736, which also lists 2 linked publications.

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 28 Apr 2021.

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