Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, and 12 months
Awards & highlights
SOLVE Trial 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.Check my eligibility
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.See study design
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.
SOLVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure is high, at or above 120/80 mmHg, with or without medication.
SOLVE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Aortic Pulse Wave Velocity
Left Atrial Ejection Fraction
Left Atrial Global Strain
+2 moreSOLVE 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.
Find a Location
Who is running the clinical trial?
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
226,246 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,524 Total Patients Enrolled
1 Trials studying Left Ventricular Hypertrophy
200 Patients Enrolled for Left Ventricular Hypertrophy
Katherine T Mills, PhDPrincipal InvestigatorTulane University
1 Previous Clinical Trials
920 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer needed chemo or radiation in the last 2 years.I have a history of heart disease.I am 40 years old or older.My kidney function is very low or I am on dialysis/have had a kidney transplant.My blood pressure is high, at or above 120/80 mmHg, with or without medication.You work night shifts or have a job that requires you to work at night regularly.You drink more than 21 alcoholic drinks in a week.
Research Study Groups:
This trial has the following groups:- Group 1: sodium reduction intervention
- Group 2: Usual Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently enrolling volunteers for this scientific experiment?
"The information found on clinicaltrials.gov shows that this medical investigation is currently open for enrolment, having first been posted on the 2nd of January 2023 and last updated on the 1st of March 2023."
Answered by AI
What are the desired results of this investigation?
"This 12 month long medical trial is primarily focused on measuring the Change in Left Ventricular Mass Index (LVMI) from its baseline. Additionally, Cardiac magnetic resonance imaging will be used to calculate secondary objectives such as maximum and minimum volumes for the left atrium, ejection fraction of the left atrium, and global strain associated with the same organ."
Answered by AI
How many individuals are being incorporated into this medical experiment?
"Correct. Per the information available on clinicaltrials.gov, this medical research is actively enrolling individuals into its study population; it was first posted in January 2nd and updated most recently on March 1st of 2023. A total of 256 participants are needed to complete the trial at a single location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger