About this trial
The proposed mechanistic trial will test the effect of dietary sodium reduction on cardiac and vascular structure and function in those with elevated blood pressure or hypertension. Findings from this study will fill the knowledge gap on the underlying mechanisms of dietary sodium intake on cardiovascular disease risk in addition to blood pressure and could provide further evidence on sodium reduction for the prevention of cardiovascular disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women aged ≥40 years. Individuals <40 years are at a low risk for clinical and subclinical CVD
Elevated BP or hypertension (systolic BP ≥120 mmHg and diastolic BP ≥80 mmHg with or without use of antihypertensive medications)
Disqualifiers
Glomerular filtration rate (eGFR) <30 or end-stage renal disease (kidney transplant or chronic dialysis)
History of cardiovascular disease
Shift worker or regularly work at night
Cancer requiring chemotherapy or radiation treatment in the previous two years
Trial design
Parallel
Treatments tested in this trial
Sodium Reduction Intervention
BehavioralThe sodium reduction intervention is a dietician-led behavioral intervention consisting of two phases, first a 3-month intensive intervention phase, followed by a 9-month maintenance phase. The overall goal of the intervention is to reduce sodium intake to \<2,300 mg per day based on the most recent guideline from the National Academies of Medicine. Both phases will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake.
Treatment groups
Trial outcomes
Primary outcomes
Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months
Cardiac magnetic resonance imaging will be used to determine LVGLS.
Change in Left Ventricular Mass Index (LVMI) from baseline to 12 months
Cardiac magnetic resonance imaging will be used to determine left ventricular mass (LVM). LVM will be indexed to body surface area.
Change in Pulse Wave Velocity (PWV) from baseline to 12 months
A carotid tonometer will be used to measure carotid-femoral PWV.
Change in Flow-Mediated Dilation (FMD) from baseline to 12 months
Endothelial-dependent FMD will be quantified using high resolution ultrasound.
Secondary outcomes
Left Ventricular Volumes
Cardiac magnetic resonance imaging will be used to determine left ventricular volumes.
Left Atrial Maximum and Minimum Volume
Cardiac magnetic resonance imaging will be used to determine left atrial maximum and minimum volumes.
Left Atrial Ejection Fraction
Cardiac magnetic resonance imaging will be used to determine left atrial ejection fraction.
Left Atrial Global Strain
Cardiac magnetic resonance imaging will be used to determine left atrial global strain.
Sponsors and contacts
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Tulane University
Lead sponsor
Johns Hopkins University
Collaborator