Salt-Sensitivity and Immunity Cell Activation (NCT03753204) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Salt-Sensitivity and Immunity Cell Activation
United States20 participantsStarted 2021-09-01
Plain-language summary
Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the normotensive population, and strong evidence indicates that reducing salt intake decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary salt contributes to blood pressure elevation, renal injury, and cardiovascular disease remains unclear. Our data indicated that monocytes exhibit salt sensitivity, and the investigators hypothesize that of salt sensitivity of these and similar immune cells correlate with the hypertensive response to salt intake. Currently, the research tools for diagnosing salt-sensitivity are costly, time consuming and laborious. In this study the investigators will identify monocyte salt-sensitivity as a marker of salt-sensitive hypertension.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is already in Phase 1/2 and is no longer recruiting new participants — is there any way I could still access information or findings from this study that might be relevant to managing my blood pressure and inflammation?
2Since this trial is studying 'salt-sensitive' blood pressure specifically, how would my doctor even determine whether my high blood pressure falls into that salt-sensitive category, and is that something worth testing before exploring any treatments?
3Given that this is a Phase 1/2 trial, meaning safety and early effectiveness are still being established, what does my doctor think about the current state of evidence linking immune cell activation and salt intake to blood pressure — and are there proven treatments I should consider in the meantime?
4This study seems to be looking at how excess salt might trigger immune system responses that raise blood pressure — is there anything I can do right now, like dietary changes, that my doctor would recommend while this kind of research is still ongoing?
5Since I can't enroll in this trial anymore, are there other active studies or clinical programs my doctor knows of that are investigating the connection between salt sensitivity, inflammation, and high blood pressure that might be worth looking into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The percent of participants with salt sensitive blood pressure