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Sodium Reduction Intervention for Heart and Blood Vessel Health

This study is investigating if reducing the amount of sodium (salt) you eat can improve the health of your heart and blood vessels. It's looking at people with high blood pressure or hypertension. The study will use a dietician-led program to help you reduce your sodium intake to less than 2,300 mg per day. Researchers will measure changes in your heart's function (Left Ventricular Global Longitudinal Strain and Left Ventricular Mass Index) and the stiffness of your blood vessels (Pulse Wave Velocity) over 12 months to see if the intervention is successful. You may be able to join if you are 40 years or older and have elevated blood pressure or hypertension. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 256 participants. It is not specified if it is randomized or blinded.
What's involved
You would participate in a dietician-led behavioral intervention for 12 months, with an intensive phase for the first 3 months and a maintenance phase for the remaining 9 months.
Compensation
Not stated in the trial record.
Follow-up
Your heart and blood vessel health will be measured at 12 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05388032

Sodium Lowering Vascular Effects Trial

Recruiting
NAAges 40+InterventionalBasic science
Tulane University
~256 participants
Updated 2024-11-22 on ClinicalTrials.gov
What's tested:Sodium Reduction Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months
Measured over 12 months
+3 more outcomes measured

Conditions

Endothelial Dysfunction
Vascular Stiffness
Left Ventricular Hypertrophy
Left Ventricular Dysfunction

Explore related trials

Endothelial dysfunctionLeft Ventricular DysfunctionLeft Ventricular HypertrophyVascular Stiffness

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Katherine T Mills, PhD · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Marigny Bostock, MA, CHES
[email protected]
504-988-4391
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months12 months

    Cardiac magnetic resonance imaging will be used to determine LVGLS.

  • Change in Left Ventricular Mass Index (LVMI) from baseline to 12 months12 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 months12 months

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

  • Change in Flow-Mediated Dilation (FMD) from baseline to 12 months12 months

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