Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Obesity Clinical Trial

— OHT  

Official title:

Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474899
• Other study ID #: RA-4-1-7565
• Status: Recruiting
• Phase: Phase 4
• Start date: June 24, 2015
• Est. completion date: June 24, 2024

Study information

• Verified date: September 2022
• Source: Royal Perth Hospital
• Contact: Revathy Carnagarin, MD
• Phone: +61 8 92240316
• Email: revathy.carnagarin[@]uwa.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 24, 2024
• Est. primary completion date: February 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Obesity

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	Dobney Hypertension Centre	Perth	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
Royal Perth Hospital	The University of Western Australia

Country where clinical trial is conducted

Australia, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring	30 weeks
Secondary	blood glucose levels	Changes in glycemic control through oral glucose tolerance test	30 weeks
Secondary	Gut microbiota profile	Change in gut microbiota assessed by short chain fatty acid	30 weeks
Secondary	Lipid levels in blood	change in triglyceride, HDL and LDL levels in blood	30 weeks