Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Phase 4

Recruiting

• Conditions: Obesity; Hypertension
• Interventions: Drug: Moxonidine 0.4 MG; Drug: Amlodipine 5mg

• Registration Number: NCT04474899
• Lead Sponsor: Royal Perth Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-06-24
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29
• Primary Completion: 2024-02-24
• Study Completion: 2024-06-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age: 25 -70 years
• (Body Mass Index) BMI≥30kg/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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phase 1	Moxonidine 0.4 MG	Moxonidine 0.4mg/daily
Phase 2	Moxonidine 0.4 MG	Amlodipine 5mg
Phase 2	Amlodipine 5mg	Amlodipine 5mg
Phase 1	Amlodipine 5mg	Moxonidine 0.4mg/daily

Primary Outcome Measures

Name	Time	Method
Blood Pressure	30 weeks	Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Gut microbiota profile	30 weeks	Change in gut microbiota assessed by short chain fatty acid
blood glucose levels	30 weeks	Changes in glycemic control through oral glucose tolerance test
Lipid levels in blood	30 weeks	change in triglyceride, HDL and LDL levels in blood

Trial Locations

Locations (1)

Dobney Hypertension Centre; 🇦🇺 Perth, Western Australia, Australia