Status:
RECRUITING
Sodium Lowering Vascular Effects Trial
Lead Sponsor:
Tulane University
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Endothelial Dysfunction
Vascular Stiffness
Eligibility:
All Genders
40+ years
Phase:
NA
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...
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 ri...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
January 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT05388032
Start Date
January 25 2023
End Date
December 31 2026
Last Update
November 22 2024
Active Locations (1)
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1
Tulane University Office of Health Research
New Orleans, Louisiana, United States, 70112