Investigating how salt affects blood pressure and immune cells
Salt-Sensitivity and Immunity Cell Activation
PHASE1; PHASE2 · Vanderbilt University Medical Center · NCT03753204
This study is testing how salt affects blood pressure and immune cells in people with high blood pressure to see if certain immune cells can help identify those who are sensitive to salt.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center (other) |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT03753204 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between salt sensitivity and hypertension by focusing on immune cells called monocytes. It will involve 20 participants who will follow a specific protocol that includes monitoring blood pressure and collecting urine samples before and during a period of salt loading. The goal is to identify monocyte salt-sensitivity as a potential marker for salt-sensitive hypertension, which could lead to better diagnostic methods. Participants will be closely monitored for safety throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with essential hypertension and a BMI between 18.5 and 24.9.
Not a fit: Patients with acute cardiovascular events, autoimmune diseases, or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools for identifying individuals with salt-sensitive hypertension, potentially reducing cardiovascular risks.
How similar studies have performed: Other studies have indicated the importance of salt sensitivity in hypertension, but this specific approach to identifying immune cell involvement is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * We will perform a pilot analysis in 20 hypertensive subjects controlled for gender (50% men, 50% women), age (18-60 years), * New or pre-existing diagnosis of essential hypertension defined as systolic blood pressure \>140 mmHg or \>90 mmHg diastolic or taking antihypertensive medications regardless of current blood pressure. * BMI (18.5-24.9). * Only subjects who give informed consent will be studied. Exclusion Criteria: * Acute cardiovascular event(s) within the previous 6 months * Claustrophobia precluding obtaining an MRI * Inability to understand the nature, scope, and possible consequences of the study or to participate in/comply with the protocol. * Current excessive alcohol or illicit drug use. * Blood pressure below the inclusion criteria levels after discontinuation of therapy * Presence of metal implants such as artificial joints. * Concomitant diabetes mellitus, type I or II. * Autoimmune disease. * Recent vaccination * Younger or older that inclusion criteria. * Pregnancy.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Annet Kirabo — Vanderbilt University Medical Center
- Study coordinator: Annet Kirabo, PhD
- Email: annet.kirabo@vanderbilt.edu
- Phone: 6153439033
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High Blood Pressure, Salt, Excess, Inflammation