The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension

The Effect of Moxonidine and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension: a Randomised, Double Blind, Active Comparator Clinical Trial

Sponsors

Lead Sponsor: Baker Heart and Diabetes Institute

Source Baker Heart and Diabetes Institute
Brief Summary

Obesity is a major risk factor for the development of hypertension. Based on population studies, risk estimates indicate that at least two-thirds of the prevalence of hypertension can be directly attributed to obesity. Obesity per se is commonly associated with activation of the sympathetic nervous system with a predominant increase in sympathetic outflow to the kidneys and the peripheral vasculature and there is now conclusive evidence that heightened sympathetic nerve activity is a major contributor to the elevation in blood pressure associated with obesity, particularly in young subjects. In line with these findings, dietary weight loss has repeatedly been demonstrated to result in reduced sympathetic nerve activity and lower blood pressure levels. Several lines of evidence have well documented the significant role of SNS activation in obesity associated hypertension and target organ damage. Weight loss is the preferred treatment option for obesity and its consequences and reduces both SNS activation and blood pressure. In the real world however, weight loss maintenance is rarely achieved in obese patients highlighting the urgent need for alternative treatment strategies. Given the crucial involvement of SNS activation in various aspects of the obesity related increase in blood pressure, target organ damage and cardiovascular risk, the use of sympatho-inhibitory agents at an early stage is an obvious choice. The investigators therefore plan to examine the effects of the centrally sympatholytic agent moxonidine on blood pressure and the morning surge in blood pressure, sympathetic activity, regression of early target organ damage (heart, kidney and endothelium), metabolic and inflammatory markers in young obese subjects with hypertension in a randomized, double-blind clinical trial with the angiotensin receptor blocker irbesartan as an active comparator to achieve similar blood pressure reductions in both groups. The investigators hypothesize that moxonidine treatment will result in significant improvements in these outcome parameters and beneficial effects beyond simple blood pressure reduction. Findings from this study could pave the way for an early and pathophysiology- tailored treatment strategy of obesity related hypertension and its detrimental consequences.

Overall Status Unknown status
Start Date 2012-01-01
Primary Completion Date 2014-01-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Microneurography (nerve recording) 6 months
Secondary Outcome
Measure Time Frame
Blood test 6 months
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Moxonidine

Description: 0.2mg/day for 2 weeks, 0.4mg/day for 6 months

Arm Group Label: Moxonidine

Other Name: Brand name = Physiotens

Intervention Type: Drug

Intervention Name: Irbesartan

Description: 75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.

Arm Group Label: Irbesartan

Eligibility

Criteria:

Inclusion Criteria: - male age 18-30 years old - presence of central obesity and hypertension - no history of cardiovascular disease or depression - not on any medication Exclusion Criteria: - history of cardiovascular disease, depression or anxiety disorder

Gender:

Male

Minimum Age:

18 Years

Maximum Age:

30 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Markus Schlaich

Phone: 03 8532 1502

Email: [email protected]

Location
Facility: Status: Contact: BakerIDI Heart and Diabetes Institute Markus Schlaich [email protected]
Location Countries

Australia

Verification Date

2012-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Baker Heart and Diabetes Institute

Investigator Full Name: Markus Schlaich

Investigator Title: A/Prof

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Moxonidine

Type: Experimental

Label: Irbesartan

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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