Neuroinflammation in Hypertension Study

Resistant Hypertension Clinical Trial

— MINIHT  

Official title:

The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478500
• Other study ID #: DHC20180023
• Status: Recruiting
• Phase: Phase 3
• Start date: July 2, 2020
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2022
• Source: Royal Perth Hospital
• Contact: Revathy Carnagarin, MD
• Phone: +61892240316
• Email: revathy.carnagarin[@]uwa.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of BP.

Description:

This is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory BP and the parameters of sympathetic and immune activation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged: 45 -65 years

• Signed informed consent

• Clinical diagnosis of Resistant Hypertension

• Daytime systolic ambulatory BP >135mmHg.

Exclusion Criteria:• eGFR of <45 mL/min/1.73m2

• History of myocardial infarction (MI) or any cardiovascular event within 3 months of screening period, clinically significant AV conduction disturbances and/or arrhythmias,

• current of past history of heart failure (LVEF =40%)

• psychotropic agents, antidepressants and NSAIDS

• alcohol consumption of >3 standard drinks.

• known hypersensitivity or contraindication to minocycline or other tetracyclines.

Related Conditions & MeSH terms

• Hypertension
• Resistant Hypertension

Intervention

Drug:
• Minocycline
Participants will be randomly assigned to receive either Minocycline 100mg twice daily or Placebo. Comprehensive testing will be performed at baseline, and at the end of the 12 week intervention phase.

Locations

Country	Name	City	State
Australia	Royal Perth Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

References & Publications (2)

Carnagarin R, Matthews V, Zaldivia MTK, Peter K, Schlaich MP. The bidirectional interaction between the sympathetic nervous system and immune mechanisms in the pathogenesis of hypertension. Br J Pharmacol. 2019 Jun;176(12):1839-1852. doi: 10.1111/bph.14481. Epub 2018 Sep 25. Review. — View Citation

Santisteban MM, Ahmari N, Carvajal JM, Zingler MB, Qi Y, Kim S, Joseph J, Garcia-Pereira F, Johnson RD, Shenoy V, Raizada MK, Zubcevic J. Involvement of bone marrow cells and neuroinflammation in hypertension. Circ Res. 2015 Jul 3;117(2):178-91. doi: 10.1161/CIRCRESAHA.117.305853. Epub 2015 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the daytime systolic blood pressure between groups after respective treatment.	Office and ambulatory blood pressures	12 weeks
Primary	Assessment of change in central and peripheral inflammation	FDG PET	12 weeks
Secondary	Change in muscle sympathetic nerve activity	Muscle sympathetic nerve activity assessed by microneurography	12 weeks
Secondary	Change in central Blood Pressure	central Blood Pressure assessed by Sphygmocor XCEL	12 weeks