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

Primary Purpose

Abdominal Obesity, Hypertension

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Moxonidine
Irbesartan
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity focused on measuring male age 18-30 years old, presence of central obesity, no history of cardiovascular disease, depression, not on any medication

Eligibility Criteria

18 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • BakerIDI Heart and Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Moxonidine

Irbesartan

Arm Description

Outcomes

Primary Outcome Measures

Microneurography (nerve recording)
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
Blood samples will be taken from antecubital vein for biochemical analyses purposes. The sampling will take place at baseline and at 6 months visit.

Full Information

First Posted
May 24, 2011
Last Updated
February 1, 2012
Sponsor
Baker Heart and Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01360710
Brief Title
The Effect of Moxonidine on Blood Pressure and Regression of Early Target Organ Damage in Young Subjects With Abdominal Obesity and Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baker Heart and Diabetes Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Hypertension
Keywords
male age 18-30 years old, presence of central obesity, no history of cardiovascular disease, depression, not on any medication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Moxonidine
Arm Type
Experimental
Arm Title
Irbesartan
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Moxonidine
Other Intervention Name(s)
Brand name = Physiotens
Intervention Description
0.2mg/day for 2 weeks, 0.4mg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.
Primary Outcome Measure Information:
Title
Microneurography (nerve recording)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Blood test
Description
Blood samples will be taken from antecubital vein for biochemical analyses purposes. The sampling will take place at baseline and at 6 months visit.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Schlaich
Phone
03 8532 1502
Email
markus.schlaich@bakeridi.edu.au
Facility Information:
Facility Name
BakerIDI Heart and Diabetes Institute
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Schlaich
Email
markus.schlaich@bakeridi.edu.au

12. IPD Sharing Statement

Learn more about this trial

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

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