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Salt-Sensitivity and Immunity Cell Activation
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.
Conditions:
🦠 High Blood Pressure 🦠 Salt; Excess 🦠 Inflammation
🗓️ Study Start (Actual) 1 September 2021
🗓️ Primary Completion (Estimated) 1 September 2025
✅ Study Completion (Estimated) 15 September 2025
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 November 2018
  • First Submitted that Met QC Criteria 21 November 2018
  • First Posted 26 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 December 2023
  • Last Update Posted 5 December 2023
  • Last Verified December 2023
I'm interested ...!!