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Dietary Sodium Reduction for High Blood Pressure (SOLVE Trial)

N/A

Recruiting

Led By Katherine T Mills, PhD

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Elevated BP or hypertension (systolic BP ≥120 mmHg and diastolic BP ≥80 mmHg with or without use of antihypertensive medications)

Be older than 18 years old

Must not have

Cancer requiring chemotherapy or radiation treatment in the previous two years

History of cardiovascular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how reducing sodium in diet affects heart & blood vessel health in those with high blood pressure, to better understand how sodium affects cardiovascular disease risk.

Who is the study for?

This trial is for men and women aged 40 or older with elevated blood pressure or hypertension. It's not suitable for those with severe kidney issues, a history of heart disease, night shift workers, recent cancer treatments, current pregnancy or breastfeeding, heavy alcohol consumers, participants in other trials, or anyone who can't meet the study requirements.

What is being tested?

The trial is examining how reducing dietary sodium affects the heart and blood vessels in people with high blood pressure. The goal is to understand better how less salt intake might prevent cardiovascular diseases beyond just lowering blood pressure.

What are the potential side effects?

While specific side effects are not listed for a sodium reduction intervention, potential general effects may include dizziness due to changes in blood pressure levels. Participants will be monitored for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood pressure is high, at or above 120/80 mmHg, with or without medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer needed chemo or radiation in the last 2 years.

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I have a history of heart disease.

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My kidney function is very low or I am on dialysis/have had a kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

+1 more

Secondary study objectives

Aortic Pulse Wave Velocity

Left Atrial Ejection Fraction

Left Atrial Global Strain

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: sodium reduction interventionExperimental Treatment1 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.

Group II: Usual DietActive Control1 Intervention

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

0 / 4Eligibility criteria met