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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
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
HRB Clinical Research Facility Galway
Galway, Ireland
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).
Time frame: 24 months
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).
Time frame: 24 months
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).
Time frame: 24 months
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).
Time frame: 24 months
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).
Time frame: 24 months
Change in 24-hour urinary sodium excretion
Change in 24-hour urinary sodium excretion from baseline to final visit (two years)
Time frame: 24 months
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)
Time frame: 24 months
Change in functional status as measured by the assessment functional status questionnaire
Time frame: 24 months
Change in eGFR (MDRD formula)
Change in eGFR (MDRD formula) from baseline to final follow-up
Time frame: 24 months
Change in eGFR(CKD-EPI formula)
Change in eGFR (CKD-EPI formula) from baseline to final follow-up
Time frame: 24 months
Change in RNA measured through PAXgene RNA blood samples
Time frame: 24 months
Number of recorded falls, syncope and pre-syncope
Time frame: 24 months
Number of cardiovascular events
Time frame: 24 months
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