Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

NCT04474899 | Unknown Phase 4 DMC

• 1 other identifier: RA-4-1-7565
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring

  30 weeks

Secondary Outcomes (3)

• blood glucose levels

  30 weeks

• Gut microbiota profile

  30 weeks

• Lipid levels in blood

  30 weeks

Study Arms (2)

Phase 1

EXPERIMENTAL

Moxonidine 0.4mg/daily

Drug: Moxonidine 0.4 MG; Drug: Amlodipine 5mg

Phase 2

EXPERIMENTAL

Amlodipine 5mg

Drug: Moxonidine 0.4 MG; Drug: Amlodipine 5mg

Interventions

Moxonidine 0.4 MG 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.

Phase 1; Phase 2

Amlodipine 5mg 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 1; Phase 2

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Perth Hospital: lead
• The University of Western Australia: collaborator

Study Sites (1)

Dobney Hypertension Centre

Perth, Western Australia, 6155, Australia

RECRUITING

Related Publications (1)

• 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.

  PMID: 29080925 BACKGROUND

MeSH Terms

Conditions

Obesity; Hypertension

Interventions

moxonidine; Amlodipine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Markus Schlaich, MD

  University of Western Australia and Royal Perth Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Revathy Carnagarin, MD

CONTACT

+61 8 92240316; revathy.carnagarin@uwa.edu.au

Anu Joyson, MSN

CONTACT

+61 8 92240390; anu.joyson@uwa.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double blind cross over study

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 17, 2020
• Study Start: June 24, 2015
• Primary Completion: February 24, 2024
• Study Completion: June 24, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)