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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02213575
Other study ID # IRB201500594 -N
Secondary ID RO1HL33610282013
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date April 15, 2024
Est. completion date October 15, 2025

Study information

Verified date May 2023
Source University of Florida
Contact Dana Leach, DNP
Phone 352-273-8933
Email leachdd@medicine.ufl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 9
Est. completion date October 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States UF Health Cardiovascular Clinic Gainesville Florida

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRI changes in the paraventricular nucleus MRI changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus) Change from baseline to 12 weeks
Primary MRI changes in the paraventricular nucleus MRI changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus) Change in Baseline to 24 weeks
Primary PET changes in the paraventricular nucleus PET changes in the paraventricular nucleus from baseline to 12 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus) Change from baseline to 12 weeks
Primary PET changes in the paraventricular nucleus PET changes in the paraventricular nucleus from baseline to 24 weeks. Increased binding in the autonomic brain regions (paraventricular nucleus) Change in Baseline to 24 weeks
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