Endothelial DysfunctionSOLVENCT05388032
Sodium Lowering Vascular Effects Trial
A study testing Sodium Reduction Intervention in people with Endothelial Dysfunction and Vascular Stiffness, run by Tulane University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Endothelial Dysfunction, Vascular Stiffness, Left Ventricular Hypertrophy
- What is being tested?
- Sodium Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Office of Health Research
New Orleans, Louisiana, 70112
About this study
Official title: A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function
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.
Read the detailed description
High dietary sodium intake increases risk of cardiovascular disease (CVD) independent of established risk factors, including blood pressure (BP). Non-BP mediated mechanisms underlying the increased risk of CVD associated with dietary sodium intake are not well understood, but observational studies suggest direct target organ damage in the heart and vasculature might play an important role. Little evidence exists from randomized controlled trials (RCTs) on target organ effects of dietary sodium reduction, and the National Academy of Medicine has recommended future research to "test the effects of different sodium intake levels on endothelial and vascular function" in order to "to better characterize the relationship between sodium intake and chronic disease". The overall objective of the proposed mechanistic trial is to test the effect of dietary sodium reduction on cardiac and vascular structure and function. Specifically, the proposed trial will test whether dietary sodium reduction (targeting a dietary sodium intake of <2,300 mg/day) will improve left ventricular mass index (LVMI), left ventricular global longitudinal strain (LVGLS), carotid-femoral pulse wave velocity (cfPWV), and flow-mediated dilation (FMD) compared to usual intake. Additionally, we will test whether this effect is independent from BP reduction. We will recruit 256 people with elevated BP or hypertension from the greater New Orleans area and randomly assign them to a dietitian-led behavioral intervention aimed at decreasing dietary sodium intake to <2,300 mg/day for 12 months or to a usual diet. Study outcomes, including cardiac magnetic resonance imaging (CMR)-determined LVMI and LVGLS, cfPWV, and FMD, will be measured at baseline, 6-month, and 12-month clinic visits using standardized protocols with stringent quality control. These outcomes are validated biomarkers for target organ damage and predict the risk of clinical CVD events. In primary analyses, the effect of sodium reduction on each subclinical CVD endpoint will be compared between the sodium reduction and usual diet groups according to the intention-to-treat principle without adjusting for covariates. In secondary analyses, changes in ambulatory and clinical BP will be adjusted to assess the BP-independent effect of dietary sodium reduction on each subclinical CVD endpoint. The proposed trial has 85% statistical power to detect a clinically significant difference in changes of the four co-primary outcomes (10 g/m2 in LVMI, 1.3% in LVGLS, 0.9 m/s in cfPWV, and 1.1% in FMD) over 12 months between the two groups at a 2-sided significance level of 0.0125 (0.05/4). Findings from this trial will fill the knowledge gap of the underlying mechanisms of dietary sodium intake on CVD risk and provide further evidence on sodium reduction for CVD prevention.
- Conditions
- Endothelial Dysfunction, Vascular Stiffness, Left Ventricular Hypertrophy, Left Ventricular Dysfunction
- Being tested
- Sodium Reduction Intervention
- Medical subject headings
- Hypertrophy, Left Ventricular, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Reduction InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months
Cardiac magnetic resonance imaging will be used to determine LVGLS.
Measured: 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.
Measured: 12 months
Change in Pulse Wave Velocity (PWV) from baseline to 12 months
A carotid tonometer will be used to measure carotid-femoral PWV.
Measured: 12 months
Change in Flow-Mediated Dilation (FMD) from baseline to 12 months
Endothelial-dependent FMD will be quantified using high resolution ultrasound.
Measured: 12 months
Secondary outcomes (5)
Left Ventricular Volumes
Cardiac magnetic resonance imaging will be used to determine left ventricular volumes.
Measured: Baseline, 6 months, and 12 months
Left Atrial Maximum and Minimum Volume
Cardiac magnetic resonance imaging will be used to determine left atrial maximum and minimum volumes.
Measured: Baseline, 6 months, and 12 months
Left Atrial Ejection Fraction
Cardiac magnetic resonance imaging will be used to determine left atrial ejection fraction.
Measured: Baseline, 6 months, and 12 months
Left Atrial Global Strain
Cardiac magnetic resonance imaging will be used to determine left atrial global strain.
Measured: Baseline, 6 months, and 12 months
Aortic Pulse Wave Velocity
Cardiac magnetic resonance imaging will be used to determine aortic pulse wave velocity.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized 1:1 into the dietitian-led behavioral intervention and usual diet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Katherine T Mills, Tulane University
- Investigators
- Katherine T Mills, PhD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388032
- Sponsor's protocol ID
- R01HL155559
- Acronym
- SOLVE
- Status last verified
- Sep 2026
- First submitted
- 17 May 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study coordinating center and sent to the PO for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, we will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic Trial of Dietary Sodium Reduction on Vascular Structure and Function
- ClinicalTrials.gov ID
- NCT05388032
- Acronym / sponsor ID
- SOLVE / R01HL155559
- Conditions
- Endothelial Dysfunction, Vascular Stiffness, Left Ventricular Hypertrophy, Left Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High dietary sodium intake increases risk of cardiovascular disease (CVD) independent of established risk factors, including blood pressure (BP). Non-BP mediated mechanisms underlying the increased risk of CVD associated with dietary sodium intake are not well understood, but observational studies suggest direct target organ damage in the heart and vasculature might play an important role. Little evidence exists from randomized controlled trials (RCTs) on target organ effects of dietary sodium reduction, and the National Academy of Medicine has recommended future research to "test the effects of different sodium intake levels on endothelial and vascular function" in order to "to better characterize the relationship between sodium intake and chronic disease". The overall objective of the proposed mechanistic trial is to test the effect of dietary sodium reduction on cardiac and vascular structure and function. Specifically, the proposed trial will test whether dietary sodium reduction (targeting a dietary sodium intake of <2,300 mg/day) will improve left ventricular mass index (LVMI), left ventricular global longitudinal strain (LVGLS), carotid-femoral pulse wave velocity (cfPWV), and flow-mediated dilation (FMD) compared to usual intake. Additionally, we will test whether this effect is independent from BP reduction. We will recruit 256 people with elevated BP or hypertension from the greater New Orleans area and randomly assign them to a dietitian-led behavioral intervention aimed at decreasing dietary sodium intake to <2,300 mg/day for 12 months or to a usual diet. Study outcomes, including cardiac magnetic resonance imaging (CMR)-determined LVMI and LVGLS, cfPWV, and FMD, will be measured at baseline, 6-month, and 12-month clinic visits using standardized protocols with stringent quality control. These outcomes are validated biomarkers for target organ damage and predict the risk of clinical CVD events. In primary analyses, the effect of sodium reduction on each subclinical CVD endpoint will be compared between the sodium reduction and usual diet groups according to the intention-to-treat principle without adjusting for covariates. In secondary analyses, changes in ambulatory and clinical BP will be adjusted to assess the BP-independent effect of dietary sodium reduction on each subclinical CVD endpoint. The proposed trial has 85% statistical power to detect a clinically significant difference in changes of the four co-primary outcomes (10 g/m2 in LVMI, 1.3% in LVGLS, 0.9 m/s in cfPWV, and 1.1% in FMD) over 12 months between the two groups at a 2-sided significance level of 0.0125 (0.05/4). Findings from this trial will fill the knowledge gap of the underlying mechanisms of dietary sodium intake on CVD risk and provide further evidence on sodium reduction for CVD prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized 1:1 into the dietitian-led behavioral intervention and usual diet.
| Arm | Type | Receives |
|---|---|---|
| sodium reduction intervention | Experimental | Behavioral: Sodium Reduction InterventionThe 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. |
| Usual Diet | No intervention | –Participants randomized to the usual diet group will receive standard care from their providers with no study intervention. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Reduction InterventionThe 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. | Behavioural | sodium reduction intervention |
Primary outcome
Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months
Time frame: 12 months
Cardiac magnetic resonance imaging will be used to determine LVGLS.
Change in Left Ventricular Mass Index (LVMI) from baseline to 12 months
Time frame: 12 months
Cardiac magnetic resonance imaging will be used to determine left ventricular mass (LVM). LVM will be indexed to body surface area.
Change in Pulse Wave Velocity (PWV) from baseline to 12 months
Time frame: 12 months
A carotid tonometer will be used to measure carotid-femoral PWV.
Change in Flow-Mediated Dilation (FMD) from baseline to 12 months
Time frame: 12 months
Endothelial-dependent FMD will be quantified using high resolution ultrasound.
5 secondary outcomes
Left Ventricular Volumes
Time frame: Baseline, 6 months, and 12 months
Left Atrial Maximum and Minimum Volume
Time frame: Baseline, 6 months, and 12 months
Left Atrial Ejection Fraction
Time frame: Baseline, 6 months, and 12 months
Left Atrial Global Strain
Time frame: Baseline, 6 months, and 12 months
Aortic Pulse Wave Velocity
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Data will be prepared by the study coordinating center and sent to the PO for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, we will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine T Mills, PhD principal investigator
Tulane University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Reduction Intervention in people with Endothelial Dysfunction and Vascular Stiffness, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Global Longitudinal Strain (LVGLS) from baseline to 12 months (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.