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Salt-Sensitivity and Immunity Cell Activation

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ClinicalTrials.gov Identifier: NCT03753204
Recruitment Status : Not yet recruiting
First Posted : November 26, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Annet Kirabo, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
High Blood Pressure Salt; Excess Inflammation Drug: Furosemide 40 mg Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be given a high salt diet and 2 liters of saline (salt loading), followed by low salt diet and furosemide or lasix (salt depletion).
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Salt-Sensitivity and Immunity Cell Activation
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Arm Intervention/treatment
Experimental: Weinberger protocol
During the Weinberger protocol, salt loading will be achieved by the combination of a high-salt diet (isocaloric, 160 mEq Na and 70 mEq K), and an infusion of 2L of saline (300 mEq Na+). Patients will have free access to water but their food will be limited to that provided by the protocol. Salt depletion will be accomplished by administering an isocaloric diet containing 10 mEq Na and 70 mEq K and continued unlimited water intake. At 8 am, 12 noon and 4 pm, subjects will be given 40 mg of furosemide or lasix orally.
Drug: Furosemide 40 mg
Blood pressure data from the monitors will be downloaded and the average of the systolic blood pressure of the day of salt loading, from 12 noon (end of the saline infusion) until 10 pm will be used as the BP for the salt-loading period of study. The average of the systolic blood pressure of the day of salt depletion, from 12 noon (second dose of furosemide) until 10 pm will be used as the BP for the salt-depleted period of study. A fall in systolic BP ≥10 mm Hg from the salt-loading to the salt-depletion periods will be used to classify a subject as salt sensitive.
Other Name: Lasix




Primary Outcome Measures :
  1. The percent of participants with salt sensitive blood pressure [ Time Frame: Over 3 days ]
    A reduction in systolic blood pressure >9 mm Hg from the salt-loading to the salt-depletion periods will be used to classify a subject as salt sensitive


Secondary Outcome Measures :
  1. Percent of participants with immune cell activation [ Time Frame: Over 3 days ]
    We will collect blood before and after a salt-loading (Weinberger) protocol and assess immune cell activation.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753204


Contacts
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Contact: Annet Kirabo, PhD 6153439033 annet.kirabo@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Annet Kirabo    615-343-9033    annet.kirabo@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Annet Kirabo Vanderbilt University Medical Center

Publications:
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Responsible Party: Annet Kirabo, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03753204     History of Changes
Other Study ID Numbers: 182038
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Furosemide
Hypertension
Inflammation
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action