Study 3: Minocycline Decreases Microglia Activation

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02213575

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Minocycline	Phase 2

Detailed Description

This study will recruit 9 subjects from NCT02133885 who will agree to undergo additional autonomic testing and imaging studies at baseline and after 3-6 months of study treatment. Specialized imaging of the brain using magnetic resonance imaging (MRI) and positron emission tomography (PET) scanning will be conducted at the Montreal Neurological Institute, in Montreal Canada.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

Anticipated Study Start Date :

Apr 15, 2022

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Oct 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Minocycline 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.	Drug: Minocycline 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.

Arm

Intervention/Treatment

Other: Minocycline

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.

Drug: Minocycline

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.

Outcome Measures

Primary Outcome Measures

MRI changes in the paraventricular nucleus [Change from baseline to 12 weeks]
MRI changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
MRI changes in the paraventricular nucleus [Change in Baseline to 24 weeks]
MRI changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
PET changes in the paraventricular nucleus [Change from baseline to 12 weeks]
PET changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)
PET changes in the paraventricular nucleus [Change in Baseline to 24 weeks]
PET changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects participating in IRB approved protocol #102-2013 will be eligible to participate.
(For Study 3 Participants only) Willing to travel to Montreal, Canada for specialized imaging of the participant's brain using magnetic resonance imaging (MRI), positron emission tomography (PET) scanning, Autonomic Nervous System Testing and blood drawing- if participant qualifies

Exclusion criteria for control and resistant hypertensive subjects include:

currently pregnant or have been pregnant in the last 6 months;
antibiotic treatment within 2 months of study enrollment;
currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
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);
history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UF Health Cardiovascular Clinic	Gainesville	Florida	United States	32610

Sponsors and Collaborators

University of Florida
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Carl Pepine, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT02213575

Other Study ID Numbers:

IRB201500594 -N
RO1HL3361028
2013-00102 Study 3
R01HL132448

First Posted:

Aug 11, 2014

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by University of Florida

Resistent Hypertension

Additional relevant MeSH terms:

Hypertension

Minocycline

Study Results

No Results Posted as of Nov 15, 2021