Minocycline for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by Carl Pepine, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Prior Safety Data

Approved in 7 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is a mechanistic study that will enroll 9 subjects who are participating in NCT02133885 (which is designed to evaluate minocycline to test the hypothesis that minocycline treatment would produce antihypertensive effects in drug-resistant neurogenic hypertensive individuals) to test whether the antihypertensive effect of minocycline is associated with a decrease in activated microglia in central nervous system autonomic regions as evidenced by changes in PET and MRI imaging.

Research Team

Carl Pepine, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals with drug-resistant high blood pressure who are already part of another study (NCT02133885). Participants must be willing to travel to Montreal, Canada for brain imaging and testing. They should not be pregnant or have been so in the last 6 months, nor taking certain medications that could affect the study's outcome.

Inclusion Criteria

I am willing to travel to Montreal, Canada for special brain scans and tests.

Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.

Exclusion Criteria

Currently pregnant or have been pregnant in the last 6 months

I have not taken antibiotics in the last 2 months.

Unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection)

Treatment Details

Interventions

• Minocycline (Tetracycline Antibiotic)

Trial Overview The trial is studying whether Minocycline can lower blood pressure by reducing microglia activation in the brain. This will be measured using advanced imaging techniques like PET and MRI scans alongside Autonomic Nervous System Testing.

Participant Groups

Group I: Minocycline Experimental Treatment 1 Intervention

Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.

Minocycline is already approved in Japan, India for the following indications:

Approved in Japan as Minopen for:

• Bacterial infections

Approved in India as Minoz for:

• Bacterial infections

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco