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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Baker IDI Heart and Diabetes Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Markus Schlaich, Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01360710
First received: May 24, 2011
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Abdominal Obesity
Hypertension
Drug: Moxonidine
Drug: Irbesartan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baker IDI Heart and Diabetes Institute:

Primary Outcome Measures:
  • Microneurography (nerve recording) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Microneurography technique will be performed on participants at baseline and 6 months post treatment to see if moxonidine has any effect in the reduction of sympathetic activiry.


Secondary Outcome Measures:
  • Blood test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood samples will be taken from antecubital vein for biochemical analyses purposes. The sampling will take place at baseline and at 6 months visit.


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxonidine Drug: Moxonidine
0.2mg/day for 2 weeks, 0.4mg/day for 6 months
Other Name: Brand name = Physiotens
Active Comparator: Irbesartan Drug: Irbesartan
75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360710

Contacts
Contact: Markus Schlaich 03 8532 1502 markus.schlaich@bakeridi.edu.au

Locations
Australia, Victoria
BakerIDI Heart and Diabetes Institute Recruiting
Prahran, Victoria, Australia, 3004
Contact: Markus Schlaich       markus.schlaich@bakeridi.edu.au   
Sponsors and Collaborators
Baker IDI Heart and Diabetes Institute
  More Information

No publications provided

Responsible Party: Markus Schlaich, A/Prof, Baker IDI Heart and Diabetes Institute
ClinicalTrials.gov Identifier: NCT01360710     History of Changes
Other Study ID Numbers: Young obese hypertension
Study First Received: May 24, 2011
Last Updated: February 1, 2012
Health Authority: Australia: TGA

Keywords provided by Baker IDI Heart and Diabetes Institute:
male age 18-30 years old
presence of central obesity
no history of cardiovascular disease, depression
not on any medication

Additional relevant MeSH terms:
Hypertension
Obesity
Obesity, Abdominal
Body Weight
Cardiovascular Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Vascular Diseases
Irbesartan
Moxonidine
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014