Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

NCT ID: NCT04474899

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-24
• Study Completion Date: 2024-06-24

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.

Conditions

Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phase 1

Moxonidine 0.4mg/daily

Group Type: EXPERIMENTAL

Moxonidine 0.4 MG

Intervention Type: DRUG

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.

Amlodipine 5mg

Intervention Type: DRUG

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.

Phase 2

Amlodipine 5mg

Group Type: EXPERIMENTAL

Moxonidine 0.4 MG

Intervention Type: DRUG

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.

Amlodipine 5mg

Intervention Type: DRUG

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.

Interventions

Moxonidine 0.4 MG

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

Amlodipine 5mg

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Western Australia

OTHER

Sponsor Role: collaborator

Royal Perth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Markus Schlaich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Markus Schlaich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Western Australia and Royal Perth Hospital

Locations

Dobney Hypertension Centre

Perth, Western Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Revathy Carnagarin, MD

Role: CONTACT

revathy.carnagarin@uwa.edu.au

+61 8 92240316

Anu Joyson, MSN

Role: CONTACT

anu.joyson@uwa.edu.au

+61 8 92240390

Facility Contacts

Markus Schlaich

Role: primary

markus.schlaich@uwa.edu.au

+61 8 92240390

Revathy Carnagarin

Role: backup

revathy.carnagarin@uwa.edu.au

+61 8 92240316

References

Carnagarin R, Gregory C, Azzam O, Hillis GS, Schultz C, Watts GF, Bell D, Matthews V, Schlaich MP. The Role of Sympatho-Inhibition in Combination Treatment of Obesity-Related Hypertension. Curr Hypertens Rep. 2017 Oct 28;19(12):99. doi: 10.1007/s11906-017-0795-1.

Reference Type: BACKGROUND

PMID: 29080925 (View on PubMed)

Other Identifiers

RA-4-1-7565

Identifier Type: -

Identifier Source: org_study_id