Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension (OHT)

Royal Perth Hospital

Status and phase: Enrolling; Phase 4

Conditions: Hypertension; Obesity

Treatments: Drug: Amlodipine 5mg; Drug: Moxonidine 0.4 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04474899

RA-4-1-7565

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

Phase 1

Experimental group

Description:

Moxonidine 0.4mg/daily

Treatment:

Drug: Moxonidine 0.4 MG

Drug: Amlodipine 5mg

Phase 2

Experimental group

Description:

Amlodipine 5mg

Treatment:

Drug: Moxonidine 0.4 MG

Drug: Amlodipine 5mg