Study 3: Minocycline Decreases Microglia Activation

Hypertension Clinical Trial

Official title:

Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients

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
• 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
• 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.

Related Conditions & MeSH terms

• Hypertension

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