Sodium Lowering Vascular Effects Trial (SOLVE)
Endothelial Dysfunction, Vascular Stiffness, Left Ventricular Hypertrophy
About this trial
This is an interventional basic science trial for Endothelial Dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Current pregnancy or breastfeeding or plans to become pregnant during the study
- Consumption of ≥21 alcoholic drinks/week
- Current participation in another lifestyle intervention or drug trial
- Current residence or planned residence that makes it difficult to meet trial requirements
- Other concerns regarding ability to meet trial requirements (at the discretion of the study coordinator)
Sites / Locations
- Tulane University Office of Health ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
sodium reduction intervention
Usual Diet
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.
Participants randomized to the usual diet group will receive standard care from their providers with no study intervention.