Sodium Lowering Vascular Effects Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorTulane University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Sodium Reduction Intervention

    Behavioral

    The 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

256 Participants
are divided into 2 treatment groups
Group A: sodium reduction interventionExperimental treatment 1 intervention
Group B: Usual DietNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months

Cardiac magnetic resonance imaging will be used to determine LVGLS.

Time frame
12 months
2

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.

Time frame
12 months
3

Change in Pulse Wave Velocity (PWV) from baseline to 12 months

A carotid tonometer will be used to measure carotid-femoral PWV.

Time frame
12 months
4

Change in Flow-Mediated Dilation (FMD) from baseline to 12 months

Endothelial-dependent FMD will be quantified using high resolution ultrasound.

Time frame
12 months

Secondary outcomes

1

Left Ventricular Volumes

Cardiac magnetic resonance imaging will be used to determine left ventricular volumes.

Time frame
Baseline, 6 months, and 12 months
2

Left Atrial Maximum and Minimum Volume

Cardiac magnetic resonance imaging will be used to determine left atrial maximum and minimum volumes.

Time frame
Baseline, 6 months, and 12 months
3

Left Atrial Ejection Fraction

Cardiac magnetic resonance imaging will be used to determine left atrial ejection fraction.

Time frame
Baseline, 6 months, and 12 months
4

Left Atrial Global Strain

Cardiac magnetic resonance imaging will be used to determine left atrial global strain.

Time frame
Baseline, 6 months, and 12 months

Other outcomes

Sponsors and contacts

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Tulane University

Lead sponsor

Johns Hopkins University

Collaborator