Sodium Lowering Vascular Effects Trial

NCT05388032 | Recruiting DMC

• 1 other identifier: R01HL155559
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

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

  Cardiac magnetic resonance imaging will be used to determine LVGLS.

  12 months

• 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.

  12 months

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

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

  12 months

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

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

  12 months

Secondary Outcomes (5)

• Left Ventricular Volumes

  Baseline, 6 months, and 12 months

• Left Atrial Maximum and Minimum Volume

  Baseline, 6 months, and 12 months

• Left Atrial Ejection Fraction

  Baseline, 6 months, and 12 months

• Left Atrial Global Strain

  Baseline, 6 months, and 12 months

• Aortic Pulse Wave Velocity

  Baseline, 6 months, and 12 months

Study Arms (2)

sodium reduction intervention

EXPERIMENTAL

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.

Behavioral: Sodium Reduction Intervention

Usual Diet

NO INTERVENTION

Participants randomized to the usual diet group will receive standard care from their providers with no study intervention.

Interventions

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.

sodium reduction intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tulane University: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Tulane University Office of Health Research

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Study Officials

• Katherine T Mills, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marigny Bostock, MA, CHES

CONTACT

504-988-4391; mbostock@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical and laboratory staff members who assess the study outcomes will be blinded to participant intervention assignment. Study participants, investigators, and study staff members who conduct the intervention cannot be blinded to intervention assignment because this is a dietary behavioral intervention trial.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Eligible participants will be randomized 1:1 into the dietitian-led behavioral intervention and usual diet.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data sets will be submitted to the NHLBI Program Official (PO) no later than 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first.
• Access Criteria: Upon request

Locations

US (1)