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Loop Diuretic

Furosemide for High Blood Pressure

Phase 1 & 2

Recruiting

Led By Annet Kirabo

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Must not have

Inability to understand the nature, scope, and possible consequences of the study or to participate in/comply with the protocol

Concomitant diabetes mellitus, type I or II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 3 days

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test whether or not salt-sensitive hypertension can be diagnosed by monocyte salt-sensitivity.

Who is the study for?

This trial is for adults aged 18-60 with a healthy BMI (18.5-24.9) who have high blood pressure, either newly diagnosed or existing, and are currently on medication or have blood pressure above certain levels. It's not open to those with diabetes, recent vaccinations, pregnancy, substance abuse issues, metal implants, autoimmune diseases, claustrophobia that prevents MRI scans or those who've had a recent heart event.

What is being tested?

The study tests if the drug Furosemide at 40 mg can be used as an indicator of salt-sensitivity in people with high blood pressure by observing immune cell activation. The goal is to see if this response correlates with hypertension due to salt intake.

What are the potential side effects?

Furosemide may cause dehydration and electrolyte imbalances leading to symptoms like dry mouth/thirsty feeling, confusion or weakness; it might also lead to increased urination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have high blood pressure or am on medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand and can follow the study's requirements.

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I have diabetes, either type 1 or 2.

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My blood pressure is low even after stopping my medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The percent of participants with salt sensitive blood pressure

Secondary study objectives

Percent of participants with immune cell activation

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Weinberger protocolExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Furosemide

FDA approved

0 / 4Eligibility criteria met