Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Royal Perth Hospital
Updated on 19 February 2024
body mass index
hypertension
amlodipine
ace inhibitor
amlodipine 5 mg
moxonidine

Summary

This study is designed to investigate whether sympathoinhibition with moxonidine could provide added metabolic benefit compared to the second line therapy in the current guidelines.

Description

This is a randomised, double-blind, cross-over study. Participants will be randomly assigned to receive either moxonidine 0.4mg daily or amlodipine 5mg and will later receive the alternate treatment.

Comprehensive testing will occur after each 12 week treatment phase and will include assessment of muscle sympathetic nerve activity, gut microbiome analysis and metabolic markers.

Details
Condition Vascular Diseases, Vascular Diseases, Hypertension, Obesity, Obesity
Age 25-65 years
Treatment Moxonidine 0.4 MG, Amlodipine 5mg
Clinical Study IdentifierNCT04474899
SponsorRoyal Perth Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 25 -65 years
(Body Mass Index) BMI30kg/m2
Currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program)
Elevated clinic systolic (Blood Pressure) BP 135 or diastolic BP 85mmHg
on ACE inhibitor for at least 6 weeks prior to baseline assessment

Exclusion Criteria

Grade 2-3 hypertension (systolic office BP >160, diastolic office BP >100 mmHg)
Secondary causes of hypertension
CKD (Chronic kidney disease) stage 4-5 {(estimated glomerular filtration) eGFR<30ml/min}
Heart failure NYHA (New York Heart Association) class II-IV
Recent CV (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) unstable psychiatric condition
medication such as corticosteroids, several antidepressants and antipsychotics
Female participants of childbearing potential must have a negative pregnancy test prior to treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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