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Sodium Lowering Vascular Effects Trial

NCT05388032 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2024-11-22

No results posted yet for this study

Summary

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.

Conditions

  • Endothelial Dysfunction
  • Vascular Stiffness
  • Left Ventricular Hypertrophy
  • Left Ventricular Dysfunction

Interventions

BEHAVIORAL

Sodium Reduction Intervention

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.

Sponsors & Collaborators

Principal Investigators

  • Katherine T Mills, PhD · Tulane University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05388032 on ClinicalTrials.gov