RECRUITING

Sodium Lowering Vascular Effects Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function

Quick Facts

Study Start:2023-01-25
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05388032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men or women aged ≥40 years. Individuals \<40 years are at a low risk for clinical and subclinical CVD
  2. * Elevated BP or hypertension (systolic BP ≥120 mmHg and diastolic BP ≥80 mmHg with or without use of antihypertensive medications)
  1. * Glomerular filtration rate (eGFR) \<30 or end-stage renal disease (kidney transplant or chronic dialysis)
  2. * History of cardiovascular disease
  3. * Shift worker or regularly work at night
  4. * Cancer requiring chemotherapy or radiation treatment in the previous two years
  5. * Current pregnancy or breastfeeding or plans to become pregnant during the study
  6. * Consumption of ≥21 alcoholic drinks/week
  7. * Current participation in another lifestyle intervention or drug trial
  8. * Current residence or planned residence that makes it difficult to meet trial requirements
  9. * Other concerns regarding ability to meet trial requirements (at the discretion of the study coordinator)

Contacts and Locations

Study Contact

Marigny Bostock, MA, CHES
CONTACT
504-988-4391
mbostock@tulane.edu

Principal Investigator

Katherine T Mills, PhD
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

Tulane University Office of Health Research
New Orleans, Louisiana, 70112
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Katherine T Mills, PhD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-25
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-01-25
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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