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

NCT ID: NCT01360710

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31

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.

Conditions

Abdominal Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Moxonidine

Group Type: EXPERIMENTAL

Moxonidine

Intervention Type: DRUG

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

Irbesartan

Group Type: ACTIVE_COMPARATOR

Irbesartan

Intervention Type: DRUG

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

Interventions

Moxonidine

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

Intervention Type: DRUG

Irbesartan

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

Intervention Type: DRUG

Other Intervention Names

Brand name = Physiotens

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Baker Heart and Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Markus Schlaich

A/Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

BakerIDI Heart and Diabetes Institute

Prahran, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Markus Schlaich

Role: CONTACT

markus.schlaich@bakeridi.edu.au

03 8532 1502

Facility Contacts

Markus Schlaich

Role: primary

markus.schlaich@bakeridi.edu.au

Other Identifiers

Young obese hypertension

Identifier Type: -

Identifier Source: org_study_id