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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04474899




Registration number
NCT04474899
Ethics application status
Date submitted
3/06/2020
Date registered
17/07/2020
Date last updated
17/07/2020

Titles & IDs
Public title
Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Scientific title
Sympathoinhibition as a Preferred Second Line Treatment of Obesity Related Hypertension
Secondary ID [1] 0 0
RA-4-1-7565
Universal Trial Number (UTN)
Trial acronym
OHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine 0.4 MG
Treatment: Drugs - Amlodipine 5mg

Experimental: Phase 1 - Moxonidine 0.4mg/daily

Experimental: Phase 2 - Amlodipine 5mg


Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Blood Pressure - Both Systolic and diastolic blood pressure assessed by office and ambulatory blood pressure monitoring
Timepoint [1] 0 0
30 weeks
Secondary outcome [1] 0 0
blood glucose levels - Changes in glycemic control through oral glucose tolerance test
Timepoint [1] 0 0
30 weeks
Secondary outcome [2] 0 0
Gut microbiota profile - Change in gut microbiota assessed by short chain fatty acid
Timepoint [2] 0 0
30 weeks
Secondary outcome [3] 0 0
Lipid levels in blood - change in triglyceride, HDL and LDL levels in blood
Timepoint [3] 0 0
30 weeks

Eligibility
Key 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
Minimum age
25 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Dobney Hypertension Centre - Perth
Recruitment postcode(s) [1] 0 0
6155 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Western Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04474899
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, MD
Address 0 0
University of Western Australia and Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Revathy Carnagarin, MD
Address 0 0
Country 0 0
Phone 0 0
+61 8 92240316
Fax 0 0
Email 0 0
revathy.carnagarin@uwa.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04474899