Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Sponsors

Lead Sponsor: Royal Perth Hospital

Collaborator: The University of Western Australia

Source 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.

Overall Status Recruiting
Start Date 2015-06-24
Completion Date 2024-06-24
Primary Completion Date 2024-02-24
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood Pressure 30 weeks
Secondary Outcome
Measure Time Frame
blood glucose levels 30 weeks
Gut microbiota profile 30 weeks
Lipid levels in blood 30 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: Moxonidine 0.4 MG

Description: Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.

Intervention Type: Drug

Intervention Name: Amlodipine 5mg

Description: Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.

Eligibility

Criteria:

Inclusion Criteria: - Age: 25 -65 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

Gender:

All

Minimum Age:

25 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Markus Schlaich, MD Principal Investigator University of Western Australia and Royal Perth Hospital
Overall Contact

Last Name: Revathy Carnagarin, MD

Phone: +61 8 92240316

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Dobney Hypertension Centre Markus Schlaich +61 8 92240390 [email protected] Markus Schlaich Principal Investigator Revathy Carnagarin Sub-Investigator
Location Countries

Australia

Verification Date

2020-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Royal Perth Hospital

Investigator Full Name: Dr Markus Schlaich

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Phase 1

Type: Experimental

Description: Moxonidine 0.4mg/daily

Label: Phase 2

Type: Experimental

Description: Amlodipine 5mg

Acronym OHT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Randomized, double blind cross over study

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Double (Participant, Investigator)

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